Ocrelizumab

also known as OCR · OCREVUS · CYB704 · ocrelizumab (Ocrevus) · Ocrelizumab component of ocrevus zunovo · Ocrelizumab-ocsq · Ocrevus (ocrelizumab) · PR-070769 · +5 more

Monoclonal antibody targets MS4A1

Developed for: multiple sclerosis · relapsing-remitting multiple sclerosis · rheumatoid arthritis · primary progressive multiple sclerosis · systemic lupus erythematosus · lupus nephritis · non-Hodgkin lymphoma · autoimmune encephalitis
+3 more
· schizoaffective disorder · schizophrenia · secondary progressive multiple sclerosis
Investigated by: Hoffmann-La Roche · Genentech, Inc. · Roche Pharma AG · Johns Hopkins University · PPD Development, LP · Illingworth Research Group
+22 more
· Laboratory Corporation of America · University of Colorado, Denver · Amsterdam UMC, location VUmc · Assistance Publique - Hôpitaux de Paris · Autoimmunity Centers of Excellence · Celltrion · Centre Hospitalier Universitaire de Nice · Chugai Pharmaceutical · Fondation Ophtalmologique Adolphe de Rothschild · Georgia State University · GlaxoSmithKline · Multiple Sclerosis Center of Atlanta · National Institute of Allergy and Infectious Diseases (NIAID) · National Multiple Sclerosis Society · Paris Brain Institute (ICM) · Polpharma Biologics International AG · Rho Federal Systems Division, Inc. · Sandoz · The Cleveland Clinic · University of California, San Francisco · University of Nottingham · Yale University

Regulatory milestones approvals, filings & regulatory actions · 10 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed primary progressive multiple sclerosis 2 milestones
Filed	EU (EMA)	Ocrevus	primary progressive multiple sclerosis	2020-04-19	“European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have accepted marketing applications for OCREVUS, each submitted for RMS and PPMS.” roche.com ↗ “the European Medicines Agency (EMA) has validated the application for a two-hour Ocrevus® (ocrelizumab) infusion time.” gene.com ↗ “the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab)” gene.com ↗ “FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time” gene.com ↗
Filed	US (FDA)	Ocrevus	primary progressive multiple sclerosis	2020-04-19	“European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have accepted marketing applications for OCREVUS, each submitted for RMS and PPMS.” roche.com ↗ “FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time” gene.com ↗
Filed progressive relapsing multiple sclerosis 2 milestones
Filed	US (FDA)	OCREVUS	progressive relapsing multiple sclerosis	2016-06-27	“The U.S. Food and Drug Administration (FDA) has also accepted for review Roche’s Biologics License Application (BLA) for OCREVUS” roche.com ↗ “FDA accepted for review the company’s Biologics License Application (BLA) for OCREVUS™” gene.com ↗
Filed	EU (EMA)	OCREVUS	progressive relapsing multiple sclerosis	2016-06-27	“the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) of OCREVUS® (ocrelizumab)” roche.com ↗ “The OCREVUS Marketing Authorization Application (MAA) has also been validated by the European Medicines Agency (EMA).” gene.com ↗
Filed relapsing-remitting multiple sclerosis 2 milestones
Filed	EU (EMA)	OCREVUS	relapsing-remitting multiple sclerosis	2017-03-29	“European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have accepted marketing applications for OCREVUS, each submitted for RMS and PPMS.” roche.com ↗ “The OCREVUS Marketing Authorisation Application (MAA) has also been validated by the European Medicines Agency (EMA) and is currently under review.” roche.com ↗ “The OCREVUS Marketing Authorization Application (MAA) has been validated by the European Medicines Agency (EMA) and is currently under review.” gene.com ↗ “The OCREVUS Marketing Authorisation Application (MAA) has been validated by the European Medicines Agency (EMA) and is currently under review.” gene.com ↗
Filed	US (FDA)	OCREVUS	relapsing-remitting multiple sclerosis	—	“European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have accepted marketing applications for OCREVUS, each submitted for RMS and PPMS.” roche.com ↗
Approved Indication not stated 3 milestones
Label expansions (2)	US (FDA)	OCREVUS	—	2020-12-14 – 2026-05-08	fda.gov ↗
Approved	EU (EMA)	Ocrevus	—	2018-01-08	europa.eu ↗
Approved	US (FDA)	OCREVUS	—	2017-03-28	fda.gov ↗

Trials 56

today

US approved 2017

EU approved 2018

NCT07503340 · Ph 3 NCT07606521 · Ph 1 NCT07609719 · Ph 4 NCT07483450 · Ph 4 NCT06847724 · Ph 3 NCT06495593 · Ph 4 NCT07667322 · Ph 1 NCT06675955 · Ph 3 NCT05906992 · Ph 3 NCT05999604 · Ph 3 NCT05208840 · Ph 4 NCT05285891 · Ph 4 NCT05123703 · Ph 3 NCT05269004 · Ph 3 NCT05296161 · Ph 4 NCT04998812 · Ph 4 NCT05210621 · Ph 3 NCT04877457 · Ph 4 NCT04767698 · Ph 2 NCT04998851 · Ph 4 NCT04650321 · Ph 4 NCT04387734 · Ph 4 NCT04261790 · Ph 4 NCT04377555 · Ph 4 NCT04075266 · Ph 2 NCT03972306 · Ph 1 NCT04035005 · Ph 3 NCT03853746 · Ph 4 NCT03535298 · Ph 4 NCT03691077 · Ph 3 NCT03606460 · Ph 3 NCT03589105 · Ph 4 NCT03599245 · Ph 3 NCT03523858 · Ph 3 NCT03085810 · Ph 3 NCT02980042 · Ph 3 NCT02861014 · Ph 3 NCT02688985 · Ph 3 NCT02637856 · Ph 3 NCT02545868 · Ph 3 NCT01412333 · Ph 3 NCT01247324 · Ph 3 NCT01194570 · Ph 3 NCT00808210 · Ph 2 NCT00779220 · Ph 2 NCT00676715 · Ph 2 NCT00673920 · Ph 3 NCT00626197 · Ph 3 NCT00539838 · Ph 3 NCT00485589 · Ph 3 NCT00476996 · Ph 3 NCT00406419 · Ph 3 NCT02720120 · Ph 1/2 NCT02723071 · Ph 1/2 NCT00077870 · Ph 1/2

20042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 13 trials
Phase 1	NCT07606521	Oct 2026 → Dec 2027 expected	multiple sclerosis	Polpharma Biologics International AG	Not yet recruiting	No outcome recorded
Phase 1	NCT07667322	Dec 2024 → Feb 2028 expected	multiple sclerosis	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 1	NCT03972306	Aug 2019 → Jun 2025	multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1/23 trials
Phase 1/2	NCT02720120	Oct 2005 → Feb 2013	rheumatoid arthritis	Hoffmann-La Roche	Terminated	No outcome recorded
Phase 1/2	NCT02723071	May 2005 → Jan 2008	non-Hodgkin lymphoma	Hoffmann-La Roche	Completed	No outcome recorded
Phase 1/2	NCT00077870	Feb 2004 → Dec 2006	rheumatoid arthritis	Genentech, Inc.	Completed	No outcome recorded
Phase 25 trials · 2 met primary
Phase 2	NCT04767698	Oct 2021 → May 2022	multiple sclerosis	Johns Hopkins University	Terminated	No outcome recorded Stop: Business
Phase 2	NCT04075266	Jan 2020 → Oct 2023 overdue	multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 2	NCT00808210	Mar 2009 → Nov 2012	rheumatoid arthritis	Genentech, Inc.	Terminated	No outcome recorded
Phase 2	NCT00779220	Oct 2008 → Feb 2010	rheumatoid arthritis	Chugai Pharmaceutical	Terminated	Met primary
Phase 2	NCT00676715	Jul 2008 → Mar 2012	relapsing-remitting multiple sclerosis	Genentech, Inc.	Completed	Met primary
Phase 328 trials · 7 met primary · 1 missed
Phase 3	NCT07503340	Oct 2026 → Aug 2029 expected	relapsing-remitting multiple sclerosis	Hoffmann-La Roche	Not yet recruiting	No outcome recorded
Phase 3	NCT06847724	Jun 2025 → Nov 2026 expected	multiple sclerosis	Sandoz	Active not recruiting	No outcome recorded
Phase 3	NCT06675955	Dec 2024 → Dec 2029 expected	multiple sclerosis	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 3	NCT05906992	Jan 2024 → Feb 2027 expected	relapsing-remitting multiple sclerosis	Celltrion	Recruiting	No outcome recorded
Phase 3	NCT05999604	Nov 2023 → Nov 2029 expected	multiple sclerosis	Fondation Ophtalmologique Adolphe de Rothschild	Recruiting	No outcome recorded
Phase 3	NCT05123703	May 2022 → Jun 2025 overdue	relapsing-remitting multiple sclerosis	Hoffmann-La Roche	Active not recruiting	Met primary
Phase 3	NCT05269004	May 2022 → Dec 2027 expected	multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT05210621	Mar 2022 → Feb 2026 overdue	multiple sclerosis	Centre Hospitalier Universitaire de Nice	Active not recruiting	No outcome recorded
Phase 3	NCT04035005	Aug 2019 → Jan 2025 overdue	primary progressive multiple sclerosis	Hoffmann-La Roche	Active not recruiting	Met primary
Phase 3	NCT03691077	Nov 2018 → May 2024	primary progressive multiple sclerosis	Assistance Publique - Hôpitaux de Paris	Unknown	No outcome recorded
Phase 3	NCT03606460	Sep 2018 → May 2019	multiple sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 3	NCT03599245	Jul 2018 → Jul 2025	multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 3	NCT03523858	May 2018 → Oct 2026 expected	multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT03085810	Mar 2017 → Apr 2023	relapsing-remitting multiple sclerosis	Hoffmann-La Roche	Terminated	No outcome recorded
Phase 3	NCT02980042	Jan 2017 → Mar 2019	multiple sclerosis	University of Colorado, Denver	Completed	Mixed
Phase 3	NCT02861014	Sep 2016 → Oct 2019	relapsing-remitting multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 3	NCT02688985	Apr 2016 → Apr 2023	primary progressive multiple sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 3	NCT02637856	Feb 2016 → May 2019	relapsing-remitting multiple sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 3	NCT02545868	Oct 2015 → Feb 2017	relapsing-remitting multiple sclerosis	Hoffmann-La Roche	Completed	Missed primary
Phase 3	NCT01412333	Sep 2011 → May 2015	multiple sclerosis	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT01247324	Aug 2011 → Apr 2015	multiple sclerosis	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT01194570	Mar 2011 → Jul 2015	primary progressive multiple sclerosis	Hoffmann-La Roche	Completed	Met primary
Phase 3	NCT00673920	Apr 2008 → Oct 2009	rheumatoid arthritis	Genentech, Inc.	Terminated	No outcome recorded
Phase 3	NCT00626197	Feb 2008 → Oct 2009	lupus nephritis, systemic lupus erythematosus	Genentech, Inc.	Terminated	No outcome recorded
Phase 3	NCT00539838	Dec 2007 → Jul 2011	systemic lupus erythematosus	Genentech, Inc.	Terminated	No outcome recorded
Phase 3	NCT00485589	Jun 2007 → Jan 2010	rheumatoid arthritis	Genentech, Inc.	Terminated	No outcome recorded
Phase 3	NCT00476996	May 2007 → Jan 2010	rheumatoid arthritis	Genentech, Inc.	Terminated	Met primary Stop: Enrollment
Phase 3	NCT00406419	Dec 2006 → Oct 2009	rheumatoid arthritis	Genentech, Inc.	Terminated	Met primary

Phase 416 trials · 2 missed
Phase 4	NCT07609719	Sep 2026 → Feb 2029 expected	multiple sclerosis	Genentech, Inc.	Recruiting	No outcome recorded
Phase 4	NCT07483450	Jul 2025 → Dec 2027 expected	primary progressive multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 4	NCT06495593	Feb 2025 → Jun 2027 expected	relapsing-remitting multiple sclerosis	University of California, San Francisco	Enrolling by invitation	No outcome recorded
Phase 4	NCT05208840	Sep 2023 → Jan 2025	multiple sclerosis	Hoffmann-La Roche	Withdrawn	No outcome recorded
Phase 4	NCT05285891	Feb 2023 → Aug 2031 expected	multiple sclerosis	National Institute of Allergy and Infectious Diseases (NIAID)	Active not recruiting	No outcome recorded
Phase 4	NCT05296161	Apr 2022 → Feb 2027 expected	relapsing-remitting multiple sclerosis	Amsterdam UMC, location VUmc	Active not recruiting	No outcome recorded
Phase 4	NCT04998812	Apr 2022 → Apr 2024	multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT04877457	Feb 2022 → Jun 2023	multiple sclerosis	Yale University	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT04998851	Sep 2021 → Mar 2024	multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 4	NCT04650321	Mar → Aug 2021 overdue	multiple sclerosis	University of Colorado, Denver	Recruiting	No outcome recorded
Phase 4	NCT04387734	Feb 2021 → Feb 2025 overdue	multiple sclerosis	Georgia State University	Active not recruiting	No outcome recorded
Phase 4	NCT04261790	Aug 2020 → Oct 2024	relapsing-remitting multiple sclerosis	Johns Hopkins University	Completed	Missed primary
Phase 4	NCT04377555	Jul 2020 → Dec 2022	multiple sclerosis	Genentech, Inc.	Completed	No outcome recorded
Phase 4	NCT03853746	Apr 2019 → Mar 2024	multiple sclerosis	Johns Hopkins University	Completed	Missed primary
Phase 4	NCT03535298	Jan 2019 → Jul 2027 expected	relapsing-remitting multiple sclerosis	The Cleveland Clinic	Active not recruiting	No outcome recorded
Phase 4	NCT03589105	Aug 2018 → Feb 2021	multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded

Phase not stated1 trial
—	NCT02807285	—	multiple sclerosis	Genentech, Inc.	No longer available	No outcome recorded
Comparator or background therapy24 trials
Phase 1	NCT06677710 Background	Jun → Dec 2026	primary progressive multiple sclerosis, secondary progressive multiple sclerosis	Indapta Therapeutics, INC.	Suspended	No outcome recorded Stop: Business
Phase 1	NCT07597668 Comparator	Apr 2025 → Jun 2026 overdue	multiple sclerosis	R-Pharm	Active not recruiting	No outcome recorded
Phase 1/2	NCT03971487 Comparator	Oct 2019 → Jun 2028 expected	schizoaffective disorder, schizophrenia	The Methodist Hospital Research Institute	Recruiting	No outcome recorded
Phase 2	NCT07282574 Background	Mar 2026 → May 2028 expected	multiple sclerosis	Hoffmann-La Roche	Recruiting	No outcome recorded
Phase 2	NCT04971005 Comparator	Aug 2021 → Feb 2022	relapsing-remitting multiple sclerosis	University Medical Center Hamburg-Eppendorf	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT04189588 Comparator	Mar → Nov 2020	—	TerSera Therapeutics LLC	Completed	No outcome recorded
Phase 2	NCT03835728 Comparator	Jan 2019 → Oct 2020	autoimmune encephalitis	University of Texas Southwestern Medical Center	Terminated	No outcome recorded Stop: Enrollment
Phase 2/3	NCT04925557 Comparator	Nov 2021 → Jun 2023	secondary progressive multiple sclerosis	State University of New York at Buffalo	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT07189325 Comparator	Jun 2026 → Jun 2031 expected	relapsing-remitting multiple sclerosis	University Hospital, Montpellier	Recruiting	No outcome recorded
Phase 3	NCT07321093 Comparator	Nov 2025 → Dec 2028 expected	relapsing-remitting multiple sclerosis	Biocad	Recruiting	No outcome recorded
Phase 3	NCT06846281 Comparator	Jun 2025 → Jul 2029 expected	multiple sclerosis	Novartis Pharmaceuticals	Recruiting	No outcome recorded
Phase 3	NCT05758831 Comparator	Jun 2023 → Mar 2030 expected	relapsing-remitting multiple sclerosis	Rennes University Hospital	Recruiting	No outcome recorded
Phase 3	NCT05232825 Comparator	May 2022 → Mar 2023	primary progressive multiple sclerosis	Hoffmann-La Roche	Completed	No outcome recorded
Phase 3	NCT04688788 Comparator	Apr 2021 → Jun 2026 overdue	primary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis	Rigshospitalet, Denmark	Active not recruiting	No outcome recorded
Phase 3	NCT04548999 Comparator	Dec 2020 → Jun 2025 overdue	primary progressive multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT04544436 Comparator	Nov 2020 → Dec 2024 overdue	multiple sclerosis	Hoffmann-La Roche	Active not recruiting	No outcome recorded
Phase 3	NCT04578639 Comparator	Nov 2020 → Aug 2025 overdue	relapsing-remitting multiple sclerosis	Haukeland University Hospital	Active not recruiting	Met primary
Phase 3	NCT04544449 Comparator	Oct 2020 → Sep 2025 overdue	primary progressive multiple sclerosis	Hoffmann-La Roche	Active not recruiting	Met primary
Phase 3	NCT04047628 Background	Aug 2020 → Oct 2026 expected	relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis	National Institute of Allergy and Infectious Diseases (NIAID)	Recruiting	No outcome recorded
Phase 3	NCT04966338 Comparator	Aug 2019 → Nov 2020	relapsing-remitting multiple sclerosis	Cinnagen	Completed	No outcome recorded
Phase 3	NCT03477500 Comparator	Mar 2018 → Nov 2026 expected	multiple sclerosis	Haukeland University Hospital	Active not recruiting	No outcome recorded
Phase 4	NCT07389590 Comparator	Feb 2026 → Oct 2028 expected	multiple sclerosis	Johns Hopkins University	Recruiting	No outcome recorded
Phase 4	NCT04466150 Comparator	Aug 2020 → Dec 2026 expected	relapsing-remitting multiple sclerosis	University of California, San Francisco	Active not recruiting	No outcome recorded
—	NCT04519710 Background	Sep 2020 → Sep 2021	hepatitis B virus infection	Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 100

Date	Issuer	Release
2026-09-18	Hoffmann-La Roche	Regulatory CHMP recommends EU approval of Roche’s Ocrevus for children and adolescents with relapsing multiple sclerosis roche.com ↗ Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus® (ocrelizumab) intravenous (IV) infusion for the treatment of paediatric patients aged 10 years and older with relapsing forms of multiple sclerosis (RMS).
2026-02-07	Hoffmann-La Roche	Results Roche’s fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS) roche.com ↗ Late-breaking Phase III FENtrepid results presented at ACTRIMS show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, OCREVUS, in reducing disability progression in PPMS
2025-09-24	Hoffmann-La Roche	Results Roche presents new data for OCREVUS and fenebrutinib across broad patient populations at ECTRIMS 2025 roche.com ↗ New late-breaking data confirms OCREVUS significantly reduces disability progression in adults with advanced PPMS
2025-09-23	Genentech, Inc.	Results Genentech Presents New Data for Ocrevus and Fenebrutinib Across Broad Patient Populations at ECTRIMS 2025 gene.com ↗ New late-breaking data confirms Ocrevus significantly reduces disability progression in adults with advanced PPMS
2025-04-02	Hoffmann-La Roche	Results Roche provides update on Phase III OCREVUS high dose study in people with relapsing multiple sclerosis roche.com ↗ The trial did not meet its primary endpoint; results support OCREVUS IV 600 mg as the optimal dose to slow disability progression
2025-04-02	Genentech, Inc.	Results Genentech Provides Update on Phase III Ocrevus High Dose Study in People With Relapsing Multiple Sclerosis gene.com ↗ The trial did not meet its primary endpoint; results support Ocrevus IV 600 mg as the optimal dose to slow disability progression
2024-09-16	Hoffmann-La Roche	Regulatory FDA approves OCREVUS ZUNOVO™ as the first and only twice-a-year 10-minute subcutaneous injection for people with relapsing and progressive multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the United States Food and Drug Administration (U.S. FDA) has approved OCREVUS ZUNOVO™ (ocrelizumab & hyaluronidase-ocsq) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
2024-09-13	Genentech, Inc.	Regulatory FDA Approves Ocrevus Zunovo™ as the First and Only Twice-A-Year 10-Minute Subcutaneous Injection for People With Relapsing and Progressive Multiple Sclerosis gene.com ↗
2024-09-13	Halozyme Therapeutics	Regulatory Halozyme Announces FDA Approval of Roche's Subcutaneous OCREVUS ZUNOVO™ with ENHANZE® for People with Relapsing and Primary Progressive Multiple Sclerosis halozyme.com ↗ today announced that Roche received U.S. Food and Drug Administration (FDA) approval for OCREVUS ZUNOVO™
2024-06-25	Hoffmann-La Roche	Regulatory Roche’s OCREVUS subcutaneous administration approved by European Commission, as first and only twice-a-year injection for relapsing and primary progressive multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for OCREVUS® (ocrelizumab) subcutaneous (SC) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
2024-06-25	Halozyme Therapeutics	Regulatory Halozyme Announces Roche's OCREVUS® SC with ENHANZE® Receives European Commission Approval for Relapsing and Primary Progressive Multiple Sclerosis halozyme.com ↗
2024-04-17	Hoffmann-La Roche	Results Roche’s subcutaneous OCREVUS one-year data demonstrates near-complete suppression of clinical relapses and brain lesions in patients with progressive and relapsing forms of MS roche.com ↗ Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.
2024-04-16	Genentech, Inc.	Results Genentech’s Subcutaneous Ocrevus One-Year Data Demonstrates Near-Complete Suppression of Clinical Relapses and Brain Lesions in Patients With Progressive and Relapsing Forms of MS gene.com ↗ Results showed near-complete suppression of clinical relapses and brain lesions in people with relapsing or primary progressive multiple sclerosis (RMS or PPMS) which reinforce the potential benefits of this investigational formulation.
2023-10-12	Hoffmann-La Roche	Results New data for Roche’s OCREVUS show that after 10 years of treatment 77% of people with relapsing multiple sclerosis were free from disability progression and 92% continue to walk unaided roche.com ↗
2023-10-11	Hoffmann-La Roche	Results Roche’s OCREVUS twice-yearly, 10-minute subcutaneous injection was non-inferior to intravenous infusion and provided near-complete suppression of brain lesions roche.com ↗ Late-breaking Phase III results show subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeks
2023-10-11	Genentech, Inc.	Results New Data for Genentech’s Ocrevus Show That After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided gene.com ↗ After 10 Years of Treatment 77% of People With Relapsing Multiple Sclerosis Were Free From Disability Progression and 92% Continue to Walk Unaided
2023-10-10	Genentech, Inc.	Results First-Ever Clinical Trial Exclusively in Black and Hispanic / Latinx People Living With Multiple Sclerosis Shows Genentech’s Ocrevus Effectively Manages Disease Activity gene.com ↗ One-year data from the trial show that Ocrevus effectively manages MS disease activity in these populations.
2023-10-10	Genentech, Inc.	Results Genentech’s Ocrevus Twice-Yearly, 10-Minute Subcutaneous Injection Was Non-Inferior to Intravenous Infusion and Provided Near-Complete Suppression of Brain Lesions gene.com ↗ Study results demonstrate the effect of Ocrevus® (ocrelizumab) as an investigational twice-yearly, 10-minute subcutaneous injection on pharmacokinetic, biomarker, and MRI measures in patients with relapsing or primary progressive multiple sclerosis (RMS or PPMS).
2023-10-02	Hoffmann-La Roche	Results Roche to present new key clinical and real-world data at ECTRIMS-ACTRIMS 2023 showcasing strength of long-term outcomes in MS and NMOSD roche.com ↗ 10-year OCREVUS efficacy and safety data show significant benefit in slowing long-term disability progression and consistent long-term safety profile in MS
2023-07-13	Hoffmann-La Roche	Results Positive Phase III results for Roche’s OCREVUS (ocrelizumab) twice a year, 10-minute subcutaneous injection in patients with multiple sclerosis roche.com ↗ OCREVUS subcutaneous injection was shown to be non-inferior to OCREVUS given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks.
2023-07-13	Halozyme Therapeutics	Results Positive Results Announced from Phase 3 OCARINA II Trial Evaluating Roche's OCREVUS® (ocrelizumab) with Halozyme's ENHANZE® Drug Delivery Technology in Patients with Multiple Sclerosis halozyme.com ↗ OCREVUS subcutaneous injection co-formulated with ENHANZE®, Halozyme's proprietary recombinant human hyaluronidase enzyme, rHuPH20, was shown to be non-inferior to OCREVUS given by intravenous infusion (IV) as measured by pharmacokinetics (levels in the blood) at 12 weeks.
2023-07-12	Genentech, Inc.	Results Positive Phase III Results for Genentech’s Ocrevus (ocrelizumab) Twice a Year, 10-Minute Subcutaneous Injection in Patients With Multiple Sclerosis gene.com ↗ Ocrevus subcutaneous injection was shown to be non-inferior to Ocrevus given by intravenous infusion (IV), as measured by pharmacokinetics (levels in the blood) over 12 weeks.
2023-04-24	Genentech, Inc.	Results Genentech Announces Industry-Leading Brain Health Research Collaborations and Latest Data Across Neuroscience Medicines at AAN 2023 Annual Meeting gene.com ↗ Long-term data to be presented demonstrate delayed MS disability with Ocrevus; reduced disease activity with Enspryng in NMOSD and with Evrysdi in SMA
2022-10-26	Hoffmann-La Roche	Results Early treatment with Roche's OCREVUS leads to reduced disease progression and healthcare costs; nine-year safety data reinforce favourable benefit-risk profile roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new OCREVUS® (ocrelizumab) data on disease progression and healthcare costs in patients with early-stage RRMS and long-term safety from all clinical trials in patients with relapsing MS (RMS) and primary progressive MS (PPMS).
2022-10-26	Genentech, Inc.	Results Early Treatment With Genentech’s Ocrevus (ocrelizumab) Leads to Reduced Disease Progression and Healthcare Costs; Nine-Year Safety Data Reinforce Favorable Benefit-Risk Profile gene.com ↗ 77% of early-stage relapsing-remitting multiple sclerosis (RRMS) patients who had not received prior treatment achieved no evidence of disease activity (NEDA) at two years
2022-10-26	Biogen	Results New Data at ECTRIMS 2022 Highlight Biogen’s Commitment to Advancing Individualized Disease Management for People Living with MS biogen.com ↗ Patient-reported outcomes favored TYSABRI ® (natalizumab) compared to Ocrevus ® (ocrelizumab); new insights on subcutaneous administration one year after approval in Germany
2022-10-19	Hoffmann-La Roche	Results Roche to present new OCREVUS (ocrelizumab) data in multiple sclerosis and continued research into neuromyelitis optica spectrum disorder at ECTRIMS 2022 roche.com ↗ OCREVUS data will show significant benefit on slowing disease activity and progression in patients with treatment-naive early-stage relapsing-remitting multiple sclerosis (RRMS)
2022-04-04	Hoffmann-La Roche	Results New data for Roche’s OCREVUS (ocrelizumab) show benefit in disability progression and cognitive decline in both secondary progressive and primary progressive multiple sclerosis roche.com ↗ 75% of patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS) achieved no evidence of progression (NEP) in a one-year interim analysis of CONSONANCE study
2022-04-03	Genentech, Inc.	Results New Data for Genentech’s Ocrevus (Ocrelizumab) Show Benefit in Disability Progression and Cognitive Decline in Both Secondary Progressive and Primary Progressive Multiple Sclerosis gene.com ↗ 75% of patients with secondary progressive multiple sclerosis (SPMS) and primary progressive MS (PPMS) achieved no evidence of progression (NEP) in a one-year interim analysis of CONSONANCE study
2022-03-25	Hoffmann-La Roche	Results Roche to present data across broad and impactful neuroscience portfolio at 2022 AAN Annual Meeting roche.com ↗ First data showing OCREVUS treatment effect on disability progression in non-active secondary progressive multiple sclerosis and further data in primary progressive MS will be presented
2022-03-24	Genentech, Inc.	Results Genentech to Present Data Across Broad and Impactful Neuroscience Portfolio at 2022 AAN Annual Meeting gene.com ↗ First data showing Ocrevus (ocrelizumab) treatment effect on disability progression in non-active secondary progressive multiple sclerosis and further data in primary progressive multiple sclerosis will be presented
2021-10-13	Hoffmann-La Roche	Results Data up to 8-years for Roche’s OCREVUS (ocrelizumab) show early and ongoing treatment significantly reduced risk of requiring a walking aid in relapsing multiple sclerosis and disability progression in primary progressive multiple sclerosis roche.com ↗
2021-10-13	Biogen	Results New Data at ECTRIMS 2021 Highlight Biogen’s Focus on Patient-Centered Outcomes and Improving the MS Patient Experience biogen.com ↗ Real-world analysis shows significantly lower risk of relapse for patients treated with TYSABRI ® compared to Ocrevus ® (ocrelizumab)
2021-10-12	Genentech, Inc.	Results New Data up to 8-Years for Genentech’s Ocrevus (ocrelizumab) Show Early and Ongoing Treatment Significantly Reduced Risk of Requiring a Walking Aid in Relapsing Multiple Sclerosis and Disability Progression in Primary Progressive Multiple Sclerosis gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced new long-term data that reinforce the benefit of early initiation and ongoing treatment of Ocrevus® (ocrelizumab) on disability progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS), as well as safety outcomes for an analysis of a shorter two-hour infusion in minority populations.
2021-10-05	Hoffmann-La Roche	Results Roche to present new data on OCREVUS in multiple sclerosis and ENSPRYNG in neuromyelitis optica spectrum disorder at ECTRIMS 2021 roche.com ↗
2021-06-15	Hoffmann-La Roche	Results Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio roche.com ↗ OCREVUS improved work productivity over two years, which correlated with reduced symptom burden and improvement in the physical and psychological impacts of MS.
2021-04-16	Hoffmann-La Roche	Results New data for Roche’s OCREVUS (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis roche.com ↗
2021-04-16	Biogen	Results New Data at AAN 2021 from Across Biogen’s MS Portfolio Demonstrate Positive Impact of Treatment on People Living with Relapsing Multiple Sclerosis biogen.com ↗ New findings from MS PATHS show that treatment with TYSABRI ® (natalizumab) can lead to meaningful improvements in mental and social health compared to Ocrevus ® (ocrelizumab)
2021-04-15	Genentech, Inc.	Results New Data for Genentech’s Ocrevus (ocrelizumab) Reinforce Significant Benefit on Slowing Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗ Ocrevus significantly slowed loss of brain tissue within T2 MRI lesions in primary progressive multiple sclerosis (PPMS) in post-hoc analysis of Phase III ORATORIO study
2021-04-08	Hoffmann-La Roche	Results New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio roche.com ↗ OCREVUS data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS)
2021-04-07	Genentech, Inc.	Results New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio gene.com ↗ Ocrevus (ocrelizumab) data show its consistent benefit on slowing disease progression in relapsing multiple sclerosis (RMS) and primary progressive MS (PPMS)
2020-12-14	Hoffmann-La Roche	Regulatory FDA approves Roche’s OCREVUS® (ocrelizumab) shorter 2-hour infusion for relapsing and primary progressive multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a shorter two-hour infusion time for OCREVUS® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have not experienced any prior serious infusion reactions (IRs).
2020-12-14	Genentech, Inc.	Regulatory FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗ FDA Approves Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion for Relapsing and Primary Progressive Multiple Sclerosis
2020-09-11	Hoffmann-La Roche	Results New data further reinforce Roche’s OCREVUS (ocrelizumab) as a highly effective treatment for people with multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new data that show OCREVUS® (ocrelizumab) is a highly effective treatment option for people with relapsing-remitting multiple sclerosis (RRMS) who experienced a suboptimal response to their prior disease modifying therapy (DMT).
2020-09-11	Biogen	Results New Data at ACTRIMS-ECTRIMS Meeting Showcase Safety and Efficacy of Biogen’s Industry-Leading MS Portfolio biogen.com ↗
2020-09-10	Genentech, Inc.	Results New Data Further Reinforce Genentech’s Ocrevus (ocrelizumab) as a Highly Effective Treatment for People With Multiple Sclerosis gene.com ↗ 75% of patients with relapsing-remitting multiple sclerosis (RRMS) and suboptimal response to prior treatment had no evidence of disease activity two years after switching to Ocrevus in open-label Phase IIIb CASTING study
2020-09-03	Hoffmann-La Roche	Results Roche to present new data in multiple sclerosis and neuromyelitis optica spectrum disorder at MSVirtual2020 roche.com ↗ New data further reinforce OCREVUS (ocrelizumab) as a highly effective treatment option offering a favourable and consistent benefit:risk profile, with high treatment persistence and adherence
2020-09-02	Genentech, Inc.	Results Genentech to Present New Data in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder at MSVirtual2020 gene.com ↗ New data further reinforce Ocrevus (ocrelizumab) as a highly effective treatment option offering a favorable and consistent benefit:risk profile, with high treatment persistence and adherence
2020-05-28	Hoffmann-La Roche	Regulatory Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time approved in Europe roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced European Medicines Agency (EMA) approval of a new, shorter two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly, for relapsing or primary progressive multiple sclerosis (MS).
2020-04-28	Hoffmann-La Roche	Results New 6-year data for Roche’s OCREVUS (ocrelizumab) show earlier treatment initiation nearly halves risk of needing walking aid in relapsing multiple sclerosis roche.com ↗ Post-hoc analysis from 6 years of Phase III open-label extension studies showed OCREVUS treatment reduced the risk of needing a walking aid (EDSS≥6) by 49% in relapsing multiple sclerosis (RMS) patients compared with patients who switched from interferon beta-1a two years later
2020-04-27	Genentech, Inc.	Results New 6-Year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis gene.com ↗ New 6-Year Data for Genentech’s Ocrevus (ocrelizumab) Show Earlier Treatment Initiation Nearly Halves Risk of Needing Walking Aid in Relapsing Multiple Sclerosis
2020-04-20	Hoffmann-La Roche	Regulatory US FDA and EMA accept applications for Roche’s OCREVUS (ocrelizumab) shorter 2-hour infusion time roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and the European Medicines Agency (EMA) has validated the application for a two-hour OCREVUS® (ocrelizumab) infusion time, dosed twice yearly for relapsing or primary progressive multiple sclerosis (MS).
2020-04-19	Genentech, Inc.	Regulatory FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time gene.com ↗ FDA and EMA Accept Applications for Genentech’s Ocrevus (ocrelizumab) Shorter 2-Hour Infusion Time
2019-09-13	Hoffmann-La Roche	Results Roche presents new 6-year OCREVUS (ocrelizumab) data which showed that earlier initiation and continuation of treatment reduced disability progression in multiple sclerosis roche.com ↗ These results suggest earlier treatment with OCREVUS reduced the risk of disability progression and this effect was sustained over time.
2019-09-12	Genentech, Inc.	Results Genentech Presents New Six-Year Ocrevus (Ocrelizumab) Data Which Showed That Earlier Initiation and Continuation of Treatment Reduced Disability Progression in Multiple Sclerosis gene.com ↗ These results suggest earlier treatment with Ocrevus reduced the risk of disability progression and this effect was sustained over time.
2019-09-10	Hoffmann-La Roche	Results Roche presents new OCREVUS (ocrelizumab) biomarker data that increase understanding of disease progression in multiple sclerosis at ECTRIMS roche.com ↗ In the Phase III OPERA I study in RMS and the ORATORIO study in PPMS, blood NfL levels were significantly lower after treatment with OCREVUS.
2019-09-09	Genentech, Inc.	Results Genentech Presents New Ocrevus (Ocrelizumab) Biomarker Data That Increase Understanding of Disease Progression in Multiple Sclerosis at ECTRIMS gene.com ↗ In the Phase III OPERA I study in RMS and the ORATORIO study in PPMS, blood NfL levels were significantly lower after treatment with Ocrevus.
2019-09-04	Hoffmann-La Roche	Results Roche to present pivotal data for satralizumab in neuromyelitis optica spectrum disorder and six-year OCREVUS data in multiple sclerosis at ECTRIMS roche.com ↗ Additionally, longer-term data of more than six years to be presented continue to show consistent safety and efficacy outcomes for patients treated with OCREVUS earlier.
2019-09-03	Genentech, Inc.	Results Genentech to Present Pivotal Data for Satralizumab in Neuromyelitis Optica Spectrum Disorder and Six-Year Ocrevus (Ocrelizumab) Data in Multiple Sclerosis at ECTRIMS gene.com ↗ New data provide insights into neurofilament light chain (NfL) levels as a potential biomarker for predicting multiple sclerosis (MS) disability progression; new longer-term Ocrevus data of more than six years show reduction of disability progression in relapsing and primary progressive MS
2019-05-08	Hoffmann-La Roche	Results Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting roche.com ↗ New analyses on OCREVUS show its effect on reducing the risk of disability progression is associated with higher exposure to the medicine and lower B-cell levels, and show the positive impact of OCREVUS in significantly reducing disability progression.
2019-05-07	Genentech, Inc.	Results Genentech to Present New OCREVUS (ocrelizumab) Data Analyses Showing Significant Reduction of Disability Progression in Relapsing and Primary Progressive Multiple Sclerosis at the AAN Annual Meeting gene.com ↗ New analyses on OCREVUS show its effect on reducing the risk of disability progression is associated with higher exposure to the medicine and lower B-cell levels, and show the positive impact of OCREVUS in significantly reducing disability progression.
2019-04-29	Hoffmann-La Roche	Results New Roche data at the 2019 AAN Annual Meeting showcase breadth and promise of neuroscience portfolio roche.com ↗ New analyses in relapsing and primary progressive multiple sclerosis suggest that higher OCREVUS (ocrelizumab) exposure and lower B-cell levels are important for control of disability progression
2019-04-28	Genentech, Inc.	Results New Genentech Data at the 2019 AAN Annual Meeting Showcase Breadth and Promise of Neuroscience Portfolio gene.com ↗ Additionally, new long-term data from the Phase III OPERA and ORATORIO open-label extension trials showed earlier treatment with OCREVUS significantly reduced the risk of permanent disability progression.
2018-10-10	Hoffmann-La Roche	Results OCREVUS (ocrelizumab) data show early initiation of treatment reduces disability progression over five years in relapsing and primary progressive multiple sclerosis roche.com ↗ People with relapsing MS (RMS) treated sooner with OCREVUS had earlier reduction in disease activity and less disability progression vs. those who switched from interferon beta-1a
2018-10-09	Genentech, Inc.	Results OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression over Five Years in Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗ OCREVUS (Ocrelizumab) Data Show Early Initiation of Treatment Reduces Disability Progression over Five Years in Relapsing and Primary Progressive Multiple Sclerosis
2018-10-02	Hoffmann-La Roche	Results Roche to present five-year OCREVUS (ocrelizumab) efficacy and safety data in relapsing and primary progressive multiple sclerosis (MS) at ECTRIMS roche.com ↗ A greater proportion of patients of African descent treated with OCREVUS achieved no evidence of disease progression (NEDA) compared with interferon beta-1a (46 percent vs. 10 percent, respectively; p=0.002).
2018-10-01	Genentech, Inc.	Results Genentech to Present Five-Year OCREVUS (Ocrelizumab) Efficacy and Safety Data in Relapsing and Primary Progressive Multiple Sclerosis at ECTRIMS gene.com ↗ These analyses informed the ORATORIO-HAND trial, which for the first time ever will use the 9-HPT as the primary outcome to evaluate the long-term efficacy and safety of OCREVUS in people with PPMS including those later in their disease course.
2018-06-14	Hoffmann-La Roche	Results Roche announces new OCREVUS (ocrelizumab) data on long-term disability benefits in primary progressive multiple sclerosis and initiation of two global studies in progressive multiple sclerosis roche.com ↗ The new Phase III data analyses show OCREVUS may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis (PPMS).
2018-06-13	Genentech, Inc.	Results Genentech Announces New Ocrevus (Ocrelizumab) Data on Long-Term Disability Benefits in Primary Progressive Multiple Sclerosis and Initiation of two Global Studies in Progressive MS gene.com ↗ The new Phase III data analyses show OCREVUS may provide meaningful disability benefits such as delay in the need for a wheelchair for people with primary progressive multiple sclerosis (PPMS).
2018-04-23	Hoffmann-La Roche	Results New OCREVUS (ocrelizumab) data at AAN demonstrate significant reductions in disease activity and disability progression in relapsing multiple sclerosis roche.com ↗ A second four-year analysis presented in a poster at AAN showed people who stayed on OCREVUS through year two of the OLE period sustained low annualised relapse rates (ARR) and 24-week confirmed disability progression (CDP24).
2018-04-22	Genentech, Inc.	Results New OCREVUS (Ocrelizumab) Data at AAN Demonstrate Significant Reductions in Disease Activity and Disability Progression in Relapsing Multiple Sclerosis gene.com ↗ The data showcase the efficacy of OCREVUS in relapsing multiple sclerosis (RMS) through several measures of underlying disease activity and disability progression, including magnetic resonance imaging (MRI), cognitive function, and spinal fluid biomarkers of inflammation and neurodegeneration.
2018-04-16	Hoffmann-La Roche	Results Roche to present new data at AAN highlighting extensive research for OCREVUS and expanding neuroscience pipeline roche.com ↗ OCREVUS data will show significant and sustained efficacy as well as benefits in cognition in people with relapsing MS (RMS).
2018-01-12	Hoffmann-La Roche	Regulatory Roche’s OCREVUS (ocrelizumab) approved in the European Union for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis roche.com ↗
2017-11-10	Hoffmann-La Roche	Regulatory Roche’s OCREVUS (ocrelizumab) gains positive CHMP opinion for relapsing forms of multiple sclerosis and primary progressive multiple sclerosis roche.com ↗
2017-10-27	Hoffmann-La Roche	Results New OCREVUS (ocrelizumab) data at ECTRIMS advance clinical understanding of underlying progression in multiple sclerosis roche.com ↗ OCREVUS significantly reduced the proportion of people with RMS who experienced Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis compared to Rebif® (interferon-beta 1a).
2017-10-26	Genentech, Inc.	Results New OCREVUS (Ocrelizumab) Data at ECTRIMS Advance Clinical Understanding of Underlying Progression in Multiple Sclerosis gene.com ↗ OCREVUS significantly reduced the proportion of people with RMS who experienced Progression Independent of Relapse Activity (PIRA) in a post-hoc analysis compared to Rebif® (interferon-beta 1a).
2017-09-28	Hoffmann-La Roche	Regulatory Roche’s OCREVUS (ocrelizumab) approved in Switzerland for primary progressive and relapsing forms of multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Swiss agency for the authorisation and supervision of therapeutic products (Swissmedic) has granted authorisation of OCREVUS® (ocrelizumab) for the treatment of adult patients with active relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
2017-07-17	Hoffmann-La Roche	Regulatory Roche’s OCREVUS (ocrelizumab) approved for relapsing and primary progressive multiple sclerosis in Australia roche.com ↗
2017-06-23	Hoffmann-La Roche	Results New data at EAN show Roche’s OCREVUS (ocrelizumab) significantly reduced multiple measures of disease progression in relapsing and primary progressive multiple sclerosis roche.com ↗ OCREVUS significantly increased the proportion of patients maintaining NEPAD by 82 percent compared with Rebif® (interferon beta-1a) at 96 weeks in a pooled exploratory analysis of the Phase III OPERA I and II studies (p<0.001).
2017-06-22	Genentech, Inc.	Results New Data at EAN Show Genentech’s Ocrevus (Ocrelizumab) Significantly Reduced Multiple Measures of Disease Progression in Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗ In RMS, OCREVUS significantly increased the proportion of patients maintaining NEPAD by 82 percent compared with Rebif® (interferon beta-1a) at 96 weeks in a pooled exploratory analysis of the Phase III OPERA I and II studies (p<0.0001).
2017-04-26	Hoffmann-La Roche	Results New data at AAN reinforce clinical benefit of Roche's OCREVUS™ (ocrelizumab) for relapsing and primary progressive multiple sclerosis roche.com ↗ Within the first eight weeks of treatment, OCREVUS reduced the relapse rate by 55 percent compared with Rebif® (interferon beta-1a) (p=0.0045), in a pooled exploratory analysis of the Phase III OPERA I and OPERA II studies in RMS.
2017-04-25	Genentech, Inc.	Results New Data at AAN Reinforce Clinical Benefit of Genentech’s Ocrevus (Ocrelizumab) for Relapsing and Primary Progressive Multiple Sclerosis gene.com ↗ Within the first eight weeks of treatment, OCREVUS reduced the relapse rate by 55 percent compared with Rebif® (interferon beta-1a) (p=0.0045), in a pooled exploratory analysis of the Phase III OPERA I and OPERA II studies in RMS.
2017-03-29	Hoffmann-La Roche	Regulatory FDA approves Roche’s OCREVUS™ (ocrelizumab) for relapsing and primary progressive forms of multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis.
2017-03-28	Genentech, Inc.	Regulatory FDA Approves Genentech’s OCREVUS™ (Ocrelizumab) For Relapsing and Primary Progressive Forms of Multiple Sclerosis gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) approved OCREVUS™ (ocrelizumab) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis.
2016-12-21	Hoffmann-La Roche	Results Positive Phase III results for Roche’s investigational medicine OCREVUS® (ocrelizumab) published in New England Journal of Medicine roche.com ↗ Data from the OCREVUS Phase III studies showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif® (interferon beta-1a) in RMS and with placebo in PPMS.
2016-12-21	Genentech, Inc.	Results Positive Phase III Results of Genentech’s Investigational Medicine Ocrevus™ (Ocrelizumab) Published in New England Journal of Medicine gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that data from three Phase III studies of its investigational medicine OCREVUS™ (ocrelizumab) – the OPERA I and OPERA II studies in relapsing multiple sclerosis (RMS) and the ORATORIO study in primary progressive multiple sclerosis (PPMS) – were published in the December 21, 2016 online issue of the New England Journal of Medicine (NEJM).
2016-12-20	Hoffmann-La Roche	Regulatory FDA extends review of application for OCREVUS™ (ocrelizumab) roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics Licence Application (BLA) of OCREVUS™ (ocrelizumab) to 28th March 2017.
2016-12-20	Genentech, Inc.	Regulatory FDA Extends Review of Application for OCREVUS™ (Ocrelizumab) gene.com ↗ Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) of OCREVUS™ (ocrelizumab) to March 28, 2017.
2016-09-14	Hoffmann-La Roche	Results Phase III efficacy results of investigational medicine OCREVUS® (ocrelizumab) reinforced by exploratory analyses in two forms of multiple sclerosis roche.com ↗ The data showed that OCREVUS significantly increased the proportion of RMS patients achieving NEDA by 75 percent compared with interferon beta-1a over 96 weeks (0-96 weeks, p<0.0001).
2016-09-13	Genentech, Inc.	Results Phase III Efficacy Results of Investigational Medicine Ocrevus™ (Ocrelizumab) Reinforced by Exploratory Analyses in Two Forms of Multiple Sclerosis gene.com ↗ OCREVUS increased disease control in patients with RMS and PPMS in separate post-hoc analyses.
2016-06-28	Hoffmann-La Roche	Regulatory Roche's marketing applications for review of OCREVUS® (ocrelizumab) in two forms of multiple sclerosis accepted by EMA and FDA roche.com ↗ Validation confirms that the submission is complete and signifies the MAA is under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
2016-06-27	Genentech, Inc.	Regulatory FDA Grants Priority Review for Genentech’s OCREVUS™ (Ocrelizumab) Biologics License Application gene.com ↗ FDA Grants Priority Review for Genentech’s OCREVUS™ (Ocrelizumab) Biologics License Application
2016-04-19	Hoffmann-La Roche	Regulatory Roche reports solid sales growth in the first quarter of 2016 roche.com ↗ The FDA granted priority review for atezolizumab in two indications and breakthrough therapy designation for ocrelizumab in primary progressive multiple sclerosis.
2016-04-12	Hoffmann-La Roche	Results Roche to present new data at AAN showing superior efficacy of investigational medicine ocrelizumab versus comparators on disease activity and progression in two forms of multiple sclerosis roche.com ↗ The data being presented at AAN show that ocrelizumab significantly reduced disability progression and brain tissue damage in both relapsing and primary progressive forms of MS,
2016-04-12	Genentech, Inc.	Results Genentech to Present New Data at AAN Showing Superior Efficacy of Investigational Medicine Ocrelizumab Versus Comparators on Disease Activity and Progression in Two Forms of Multiple Sclerosis gene.com ↗
2016-02-17	Hoffmann-La Roche	Regulatory U.S. FDA grants Breakthrough Therapy Designation for Roche's investigational medicine ocrelizumab in primary progressive multiple sclerosis roche.com ↗ Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS).
2016-02-16	Genentech, Inc.	Regulatory FDA Grants Breakthrough Therapy Designation for Genentech’s Investigational Medicine Ocrelizumab in Primary Progressive Multiple Sclerosis gene.com ↗ Ocrelizumab is the first investigational medicine to receive Breakthrough Therapy Designation in multiple sclerosis (MS)
2015-10-08	Genentech, Inc.	Results Genentech’s Ocrelizumab First Investigational Medicine to Show Positive Pivotal Study Results in Both Relapsing and Primary Progressive Forms of Multiple Sclerosis gene.com ↗ Genentech, a member of the Roche group (SIX: RO, ROG; OTCQX: RHHBY) today announced data from three positive, pivotal Phase III studies of ocrelizumab in people with relapsing multiple sclerosis (MS) and primary progressive multiple sclerosis (PPMS).
2015-09-27	Genentech, Inc.	Results Genentech’s Ocrelizumab First Investigational Medicine to Show Efficacy in People with Primary Progressive Multiple Sclerosis in Large Phase III Study gene.com ↗ The study (called ORATORIO) met its primary endpoint, showing treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by the Expanded Disability Status Scale (EDSS).
2015-06-29	Genentech, Inc.	Results Genentech’s ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif®) in Two Phase III Studies in Multiple Sclerosis gene.com ↗ Treatment with ocrelizumab significantly reduced the annualized relapse rate (ARR) over a two-year period compared with interferon beta-1a, the primary endpoint in both studies.

All press releases naming this drug 113 releases

Date	Issuer	Release
Show all 113 releases opens the full record — a long page

Evidence & citations 18 cited values

Every value below carries the sentence it was read from. 86 sources stand behind the page.

Field	Value	Cited text
Known as	Ocrelizumab	“The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant...” NCT07609719 ↗ 77 “The phase IIIb A Study to Evaluate the Effects of Ocrelizumab on Immune Responses in Participants With Relapsing Forms of Multiple Sclerosis (VELOCE) study (NCT02545868)...” PMID 32727835 ↗ Jul 2020 “PB018, containing the active ingredient ocrelizumab, is a humanized monoclonal antibody that is being developed as a proposed biosimilar medicinal product to Ocrevus.” NCT07606521 ↗ “Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.” NCT06847724 ↗ “ocrelizumab (Ocrevus®)” NCT04047628 ↗ “Ocrevus (ocrelizumab)” NCT03535298 ↗ “CT-P53(Ocrelizumab)” NCT05906992 ↗ “Ocrelizumab” NCT06847724 ↗ NCT02723071 ↗ NCT04261790 ↗ NCT04998851 ↗ Show 67 more sources
Known as	CYB704	“Drug: CYB704 (Ocrelizumab) Patients will be dosed 300 mg on day 1 and day 15. Subsequent dose of 600 mg will be administered 24 weeks after the initial dose.” NCT06847724 ↗
Known as	OCR	“The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant...” NCT07609719 ↗ 4 “To evaluate the safety and efficacy of ocrelizumab (OCR) in Japanese patients with rheumatoid arthritis (RA) with an inadequate response to methotrexate (MTX).” PMID 22247354 ↗ Jan 2012 “Ocrelizumab (OCR), a humanized anti-CD20 monoclonal antibody, is highly efficient in relapsing-remitting multiple sclerosis (RR-MS).” PMID 40781066 ↗ Aug 2025 “The objective was to determine the safety of ocrelizumab (OCR) in patients with rheumatoid arthritis (RA).” PMID 24498318 ↗ Feb 2014 NCT02545868 ↗
Known as	ocrelizumab (Ocrevus)	“ocrelizumab (Ocrevus®)” NCT04047628 ↗
Known as	Ocrelizumab component of ocrevus zunovo	ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗
Known as	Ocrelizumab-ocsq	ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗
Known as	OCREVUS	“who decided together with their treating physician to continue on, or start treatment with, OCREVUS (ocrelizumab) post-partum.” NCT04998851 ↗ 4 “Ocrelizumab Injection [Ocrevus]” NCT05999604 ↗ “Ocrevus” NCT04189588 ↗ NCT04925557 ↗ NCT07597668 ↗
Known as	Ocrevus (ocrelizumab)	“Ocrevus (ocrelizumab)” NCT03535298 ↗
Known as	PR-070769	ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗
Known as	PRO70769	“Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗
Known as	R-1594	ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗
Known as	RG-1594	ChEMBL registry synonym — accepted as the source's own label CHEMBL2108041 ↗
Known as	rhuMAb 2H7	“Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗
Known as	RO4964913	“Ocrelizumab (rhuMAb 2H7, RO4964913, PRO70769)” NCT02720120 ↗
Action	Deplete	“Peripheral B cell depletion after infusion was rapid at all doses” PMID 18759293 ↗ Sep 2008
Modality	Monoclonal antibody	“Ocrelizumab, a humanized anti-CD20 monoclonal antibody” PMID 18759293 ↗ Sep 2008
Route	Intravenous	“Ocrelizumab was administered via IV infusion at a dose specified in arm description” NCT00406419 ↗
Target	MS4A1	“B-lymphocyte antigen CD20 binding agent” CHEMBL2108041 ↗