Drugs / Satralizumab
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed endocrine exophthalmos 1 milestone | |||||
| Filed | US (FDA) | Enspryng | endocrine exophthalmos | 2026-06-29 | “FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED).” gene.com ↗ “FDA has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED).” roche.com ↗ “regarding Enspryng ® (satralizumab), stating that the U.S. Food and Drug Administration (FDA) has accepted its application for the treatment of thyroid eye disease (TED).” chugai-pharm.co.jp ↗ |
| Filed myelin oligodendrocyte glycoprotein antibody-associated disease 2 milestones | |||||
| Filed | US (FDA) | Enspryng | myelin oligodendrocyte glycoprotein antibody-associated disease | 2026-09-09 | “has accepted Roche’s application for Enspryng ® (satralizumab) for the treatment of adult and adolescent patients with myelin oligodendrocyte glycoprotein antibody-associated disease” chugai-pharm.co.jp ↗ “FDA has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab)” gene.com ↗ |
| Filed | Japan (PMDA) | Enspryng | myelin oligodendrocyte glycoprotein antibody-associated disease | 2026-07-31 | “A regulatory application for an additional indication of Enspryng for “prevention of relapse in MOG antibody-associated disease” was filed in Japan” chugai-pharm.co.jp ↗ |
| Filed neuromyelitis optica spectrum disorder with anti-AQP4 antibodies 3 milestones | |||||
| Filed | Japan (PMDA) | — | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | 2019-11-08 | “filed a new drug application to the Ministry of Health, Labour and Welfare (MHLW) for satralizumab (development code: SA237)” chugai-pharm.co.jp ↗ |
| Filed | US (FDA) | — | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | 2019-10-24 | “Satralizumab, the anti-interleukin-6 (IL-6) receptor recycling antibody created by Chugai, was filed for regulatory approval in EU and the U.S..” chugai-pharm.co.jp ↗ “The U.S. Food and Drug Administration (FDA) has also accepted the company’s Biologics License Application (BLA) for satralizumab.” roche.com ↗ “The U.S. Food and Drug Administration (FDA) has also accepted the Biologics License Application (BLA) for satralizumab.” chugai-pharm.co.jp ↗ “FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder” gene.com ↗ |
| Filed | EU (EMA) | — | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | 2019-10-24 | “Satralizumab, the anti-interleukin-6 (IL-6) receptor recycling antibody created by Chugai, was filed for regulatory approval in EU and the U.S..” chugai-pharm.co.jp ↗ “The European Medicines Agency (EMA) has also validated the company’s Marketing Authorization Application (MAA) for satralizumab” gene.com ↗ “the European Medicines Agency (EMA) has validated the company’s Marketing Authorisation Application (MAA) for satralizumab” roche.com ↗ “the European Medicines Agency (EMA) has accepted the Marketing Authorization Application for satralizumab” chugai-pharm.co.jp ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Enspryng | — | 2021-06-24 | europa.eu ↗ |
| Approved | US (FDA) | ENSPRYNG | — | 2020-08-14 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05727657 | Jun 2024 | acquired aneurysmal subarachnoid hemorrhage, brain ischemia | University of Florida | Withdrawn | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06450639 | Apr 2025 → Nov 2026 expected | Duchenne muscular dystrophy | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06222827 | Jan 2024 → Mar 2027 expected | facioscapulohumeral muscular dystrophy 1 | Centre Hospitalier Universitaire de Nice | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05679570 | Jul 2022 → Apr 2026 | pulmonary arterial hypertension | International University of Health and Welfare | Completed | No outcome recorded |
| Phase 39 trials · 4 met primary | ||||||
| Phase 3 | NCT05199688 | May 2026 → Mar 2027 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT06106828 | Nov 2023 → Jul 2025 overdue | endocrine exophthalmos | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05987423 | Oct 2023 → Jul 2025 overdue | endocrine exophthalmos | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05503264 | Sep 2022 → Dec 2026 expected | anti-NMDA receptor encephalitis, limbic encephalitis with LGI1 antibodies | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05271409 | Aug 2022 → Nov 2025 overdue | myelin oligodendrocyte glycoprotein antibody-associated disease | Hoffmann-La Roche | Active not recruiting | Met primary |
| Phase 3 | NCT04963270 | Oct 2021 → Jan 2024 | generalized myasthenia gravis | Hoffmann-La Roche | Terminated | Met primary |
| Phase 3 | NCT04660539 | Mar 2021 → May 2024 | neuromyelitis optica | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02073279 | Aug 2014 → Oct 2018 | neuromyelitis optica | Hoffmann-La Roche | Completed | Met primary |
| Phase 3 | NCT02028884 | Feb 2014 → Jun 2018 | neuromyelitis optica | Hoffmann-La Roche | Completed | Met primary |
| Phase 42 trials | ||||||
| Phase 4 | NCT07010302 | Sep 2026 → Jan 2030 expected | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT05269667 | Aug 2022 → Oct 2023 | neuromyelitis optica spectrum disorder with anti-AQP4 antibodies | Hoffmann-La Roche | Terminated | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 58
| Date | Issuer | Release |
|---|---|---|
| 2026-09-10 | Hoffmann-La Roche | Regulatory U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments roche.com ↗
Basel, 10 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). |
| 2026-09-10 | Chugai Pharmaceutical | Regulatory Roche Announces U.S. FDA Grants Priority Review for Enspryng for Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD) chugai-pharm.co.jp ↗
the U.S. Food and Drug Administration (FDA) has accepted Roche’s application for Enspryng ® (satralizumab) for the treatment of adult and adolescent patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and granted Priority Review for the application |
| 2026-09-09 | Genentech, Inc. | Regulatory U.S. FDA Grants Priority Review for Genentech’s Enspryng for MOGAD, an Autoimmune Disease With No Approved Treatments gene.com ↗
U.S. FDA Grants Priority Review for Genentech’s Enspryng for MOGAD, an Autoimmune Disease With No Approved Treatments |
| 2026-07-31 | Chugai Pharmaceutical | Regulatory Chugai Files for Additional Indication of Enspryng as Japan’s Potential First Treatment for Prevention of Relapse in MOG Antibody-associated Disease chugai-pharm.co.jp ↗
A regulatory application for an additional indication of Enspryng for “prevention of relapse in MOG antibody-associated disease” was filed in Japan |
| 2026-06-30 | Hoffmann-La Roche | Regulatory FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) roche.com ↗
Basel, 30 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). |
| 2026-06-30 | Chugai Pharmaceutical | Regulatory Roche’s Announcement Regarding Enspryng (FDA Accepts Application for Thyroid Eye Disease) chugai-pharm.co.jp ↗
the U.S. Food and Drug Administration (FDA) has accepted its application for the treatment of thyroid eye disease (TED). |
| 2026-06-29 | Genentech, Inc. | Regulatory FDA Grants Priority Review To Genentech’s Application for Enspryng, the First and Only At-Home Subcutaneous Treatment Option for Thyroid Eye Disease (TED) gene.com ↗
Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to a supplemental Biologics License Application (sBLA) for Enspryng® (satralizumab) for the treatment of thyroid eye disease (TED). |
| 2026-04-22 | Chugai Pharmaceutical | Results Roche’s Announcement Regarding New Data of Enspryng for Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) chugai-pharm.co.jp ↗
The data were presented on April 21 at the 2026 American Academy of Neurology Annual Meeting in Chicago. |
| 2026-04-21 | Hoffmann-La Roche | Results Roche’s ENSPRYNG (satralizumab) reduces risk of relapses by 68% demonstrating potential to become first treatment for MOGAD roche.com ↗ |
| 2026-04-21 | Genentech, Inc. | Results Genentech’s Enspryng (Satralizumab) Reduces Risk of Relapses by 68% Demonstrating Potential to Become First Treatment for MOGAD gene.com ↗
Phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) |
| 2024-03-21 | Chugai Pharmaceutical | Results Results of Phase III Study of Enspryng in Patients with Generalized Myasthenia Gravis chugai-pharm.co.jp ↗
Statistically significant data was observed in its primary endpoint, however the results did not reach our expectations on the degree of clinical benefit. |
| 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 |
| 2023-03-24 | Chugai Pharmaceutical | Regulatory Chugai Receives Forerunner Designation for Enspryng in Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD) and Autoimmune Encephalitis (AIE) chugai-pharm.co.jp ↗ |
| 2022-03-25 | Hoffmann-La Roche | Results Roche to present data across broad and impactful neuroscience portfolio at 2022 AAN Annual Meeting roche.com ↗
Longer-term efficacy and safety for Enspryng in neuromyelitis optica spectrum disorder reinforce previously seen results |
| 2022-03-24 | Genentech, Inc. | Results Genentech to Present Data Across Broad and Impactful Neuroscience Portfolio at 2022 AAN Annual Meeting gene.com ↗
Longer-term efficacy and safety for Enspryng (satralizumab-mwge) in neuromyelitis optica spectrum disorder reinforce previously seen results |
| 2021-10-14 | Hoffmann-La Roche | Results New four-year data show Roche's ENSPRYNG significantly reduces debilitating relapses in people with neuromyelitis optica spectrum disorder roche.com ↗ |
| 2021-10-14 | Chugai Pharmaceutical | Results New Four-year Data Show Sustained Relapse Reduction by Chugai’s Enspryng in People with Neuromyelitis Optica Spectrum Disorder (NMOSD) chugai-pharm.co.jp ↗
More than 70% of people treated with Enspryng remained relapse-free after four years in the SAkuraStar (73%) and SAkuraSky (71%) open-label extension studies, reinforcing the long-term safety profile |
| 2021-10-13 | Genentech, Inc. | Results New 4-Year Data Show Genentech’s Enspryng (satralizumab-mwge) Significantly Reduces Debilitating Relapses in People With Neuromyelitis Optica Spectrum Disorder gene.com ↗ |
| 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 ↗ |
| 2021-06-28 | Hoffmann-La Roche | Regulatory Roche’s ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG® (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). |
| 2021-06-28 | Chugai Pharmaceutical | Regulatory Chugai’s Enspryng (Satralizumab) Approved by European Commission as First At-home Subcutaneous Treatment for Neuromyelitis Optica Spectrum Disorder (NMOSD) chugai-pharm.co.jp ↗
Enspryng is the first treatment approved in the EU for adolescents from 12 years of age with NMOSD. |
| 2021-06-15 | Hoffmann-La Roche | Results Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio roche.com ↗
ENSPRYNG® (satralizumab) significantly reduced risk of relapse vs placebo in adults with AQP4-IgG seropositive (AQP4-IgG+) NMOSD, with a favourable safety profile. |
| 2021-04-26 | Chugai Pharmaceutical | Regulatory CHMP Recommends EU Approval of Chugai’s Enspryng (Satralizumab) for Neuromyelitis Optica Spectrum Disorder (NMOSD) chugai-pharm.co.jp ↗
Enspryng is recommended for approval as a treatment option for people with NMOSD from 12 years of age in the EU. |
| 2021-04-23 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s ENSPRYNG (satralizumab) for adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗ |
| 2021-04-08 | Hoffmann-La Roche | Results New Roche data at 2021 AAN highlight impact and breadth of expanding neuroscience portfolio roche.com ↗
Data for ENSPRYNG in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs) |
| 2021-04-07 | Genentech, Inc. | Results New Genentech Data at 2021 AAN Highlight Impact and Breadth of Expanding Neuroscience Portfolio gene.com ↗
Data for Enspryng (satralizumab-mwge) in neuromyelitis optica spectrum disorder (NMOSD) reinforce safety and efficacy, including in patients with concomitant autoimmune diseases (CAIDs) |
| 2020-09-10 | Hoffmann-La Roche | Results New data show Roche’s ENSPRYNG (satralizumab) significantly reduces severity and risk of relapse in neuromyelitis optica spectrum disorder (NMOSD) roche.com ↗
In a post-hoc analysis of the ENSPRYNG-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies. |
| 2020-09-10 | Chugai Pharmaceutical | Results New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) chugai-pharm.co.jp ↗
In a post-hoc analysis of the Enspryng-treated group, the risk of severe relapse was reduced by 79% compared to placebo (5 of 27 [19%] vs. 12 of 34 [35%]), for patients across the double-blind periods of the SAkura studies (SAkuraSky, SAkuraStar). |
| 2020-09-09 | Genentech, Inc. | Results New Data Show Genentech’s Enspryng Significantly Reduces Severity and Risk of Relapse in Neuromyelitis Optica Spectrum DIsorder gene.com ↗
The data for Enspryng at MSVirtual2020 are promising and suggest it significantly reduces relapse severity and frequency, which are important goals of the treatment for people with NMOSD, |
| 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 Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with ENSPRYNG (satralizumab), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) |
| 2020-09-02 | Genentech, Inc. | Results Genentech to Present New Data in Multiple Sclerosis and Neuromyelitis Optica Spectrum Disorder at MSVirtual2020 gene.com ↗
New Phase III data from SAkuraStar and SAkuraSky studies demonstrate reduced severity of relapses with Enspryng (satralizumab-mwge), recently FDA-approved as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) |
| 2020-08-17 | Hoffmann-La Roche | Regulatory FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD) roche.com ↗ |
| 2020-08-17 | Chugai Pharmaceutical | Regulatory Chugai’s Enspryng (Satralizumab) Receives Regulatory Approval from FDA for Neuromyelitis Optica Spectrum Disorder chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has approved the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody, Enspryng TM (US generic name: satralizumab-mwge) (hereafter, Enspryng) created by Chugai for the treatment of adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). |
| 2020-08-14 | Genentech, Inc. | Regulatory FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder gene.com ↗
FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder |
| 2020-06-29 | Hoffmann-La Roche | Regulatory Roche’s ENSPRYNG®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum disorder roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children. |
| 2020-06-29 | Chugai Pharmaceutical | Regulatory Chugai’s Enspryng (Satraliazumab) Subcutaneous Injection 120 mg Syringe Approved in Japan for Neuromyelitis Optica Spectrum Disorder chugai-pharm.co.jp ↗ |
| 2020-05-22 | Hoffmann-La Roche | Results New longer-term data reinforce safety of Roche’s satralizumab in adults and adolescents with neuromyelitis optica spectrum disorder roche.com ↗
These data are being presented at the 6th Annual Meeting of the European Academy of Neurology (EAN) and show satralizumab was well-tolerated in a broad patient population – including adolescents, for whom there is no approved medicine. |
| 2020-05-22 | Chugai Pharmaceutical | Results New Longer-Term Safety Data of Chugai’s Satralizumab in Adults and Adolescents with Neuromyelitis Optica Spectrum Disorder Presented at EAN chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that Roche issued a press release regarding the new longer-term safety data of satralizumab (development code: SA237) for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder presented at the 6th Annual Meeting of the European Academy of Neurology. |
| 2020-05-21 | Genentech, Inc. | Results New Longer-Term Data Reinforce Safety of Genentech’s Satralizumab in Adults and Adolescents With Neuromyelitis Optica Spectrum Disorder (NMOSD) gene.com ↗
Pooled data from two pivotal Phase III open-label extension (OLE) studies show satralizumab was well-tolerated as a monotherapy or in combination with baseline immunosuppressive therapy in people with neuromyelitis optica spectrum disorder (NMOSD) |
| 2020-04-24 | Chugai Pharmaceutical | Results Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology chugai-pharm.co.jp ↗
Satralizumab monotherapy significantly reduced risk of relapse in patients with NMOSD, following a previous positive study where satralizumab was added to baseline immunosuppressant therapy. |
| 2019-12-02 | Hoffmann-La Roche | Results Positive phase III results for Roche’s satralizumab in neuromyelitis optica spectrum disorder published in the New England Journal of Medicine roche.com ↗
Satralizumab demonstrated robust efficacy, sustained for 144 weeks, in significantly reducing the risk of relapse in combination with baseline immunosuppressant therapy |
| 2019-12-01 | Genentech, Inc. | Results Positive Phase III Results for Genentech’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in the New England Journal of Medicine gene.com ↗
Satralizumab demonstrated robust efficacy, sustained for 144 weeks, in significantly reducing the risk of relapse in combination with baseline immunosuppressant therapy |
| 2019-11-29 | Chugai Pharmaceutical | Results Results from Phase III SAkuraSky Study for Chugai’s Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online chugai-pharm.co.jp ↗
Satralizumab added to baseline immunosuppressant therapy significantly reduced risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD). |
| 2019-11-08 | Chugai Pharmaceutical | Regulatory Chugai Files a New Drug Application for Satralizumab for NMOSD in Japan, Following the United States and Europe chugai-pharm.co.jp ↗ |
| 2019-10-30 | Hoffmann-La Roche | Regulatory Roche’s marketing applications for satralizumab in neuromyelitis optica spectrum disorder accepted for review by EMA and FDA roche.com ↗
The U.S. Food and Drug Administration (FDA) has also accepted the company’s Biologics License Application (BLA) for satralizumab. |
| 2019-10-30 | Chugai Pharmaceutical | Regulatory EMA and FDA Accept Marketing Applications for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) chugai-pharm.co.jp ↗
The U.S. Food and Drug Administration (FDA) has also accepted the Biologics License Application (BLA) for satralizumab. |
| 2019-10-29 | Genentech, Inc. | Regulatory FDA Accepts Genentech’s Biologics License Application for Satralizumab for Neuromyelitis Optica Spectrum Disorder 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) has accepted the company’s Biologics License Application (BLA) for satralizumab for the treatment of adults and adolescents with neuromyelitis optica spectrum disorder (NMOSD). |
| 2019-09-13 | Chugai Pharmaceutical | Regulatory Chugai Receives Orphan Drug Designation for Satralizumab in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder from the Ministry of Health, Labour and Welfare chugai-pharm.co.jp ↗
Orphan drug designation was granted based on the results from two global phase III clinical studies (SakuraStar Study and SAkuraSky Study) which showed efficacy and safety either in monotherapy or add-on therapy to baseline treatment. |
| 2019-09-12 | Hoffmann-La Roche | Results Roche’s satralizumab significantly reduced relapse risk in second positive phase III study for neuromyelitis optica spectrum roche.com ↗
Pivotal phase III SAkuraStar study shows 55% reduction in the risk of relapse for satralizumab monotherapy versus placebo presented at ECTRIMS congress 2019 |
| 2019-09-12 | Chugai Pharmaceutical | Results Chugai Presents Results from Second Positive Global Phase III Clinical Study of Satralizumab in NMOSD at ECTRIMS 2019 chugai-pharm.co.jp ↗
Following a positive study where satralizumab was added to baseline therapy, satralizumab monotherapy significantly reduced risk of relapse by 55% in patients with NMOSD. |
| 2019-09-11 | Genentech, Inc. | Results Genentech’s Satralizumab Significantly Reduced Relapse Risk in Second Positive Phase III Study for Neuromyelitis Optica Spectrum Disorder gene.com ↗
In the large (~67%) subgroup of patients seropositive for AQP4-IgG antibodies, the effect was higher with a 74% reduction in risk of relapses (HR=0.26, 95% CI: 0.11-0.63; p=0.0014). |
| 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 ↗
The primary and subgroup analyses show that satralizumab significantly reduces the risk of relapse in patients who were seropositive for aquaporin-4 auto-antibodies (AQP4-IgG), as well as the overall ITT population representative of NMOSD patients. |
| 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 ↗
The primary and subgroup analyses show that satralizumab significantly reduces the risk of relapse in patients who were seropositive for aquaporin-4 auto-antibodies (AQP4-IgG), as well as the overall intention-to-treat (ITT) population representative of NMOSD patients. |
| 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 ↗
Satralizumab significantly reduces the risk of relapse in neuromyelitis optica spectrum disorder in pivotal SAkuraSky study |
| 2019-04-28 | Genentech, Inc. | Results New Genentech Data at the 2019 AAN Annual Meeting Showcase Breadth and Promise of Neuroscience Portfolio gene.com ↗
The subgroup data shows that satralizumab significantly reduced the risk of NMOSD relapse in a clinically-relevant population, especially in AQP4-Ig positive patients, with a favorable benefit-risk profile. |
| 2018-12-19 | Chugai Pharmaceutical | Results Chugai’s Satralizumab Meets Primary Endpoint in Phase III Monotherapy Study in NMOSD chugai-pharm.co.jp ↗
A statistically significant reduction in the risk of relapse was confirmed in patients who received satralizumab, compared to those who received placebo. |
| 2018-12-19 | Chugai Pharmaceutical | Regulatory Chugai’s Satralizumab Receives FDA Breakthrough Therapy Designation for Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorders chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for Chugai’s anti-interleukin-6 (IL-6) receptor humanized recycling antibody satralizumab, an investigational medicine for neuromyelitis optica and neuromyelitis optica spectrum disorders (NMO/NMOSD). |
| 2018-10-15 | Chugai Pharmaceutical | Results Chugai Presents Results from Phase III Study of Satralizumab in NMOSD at ECTRIMS 2018 chugai-pharm.co.jp ↗
“These positive pivotal results for satralizumab, showing a significant reduction in relapses in patients, are a significant positive step in the potential treatment of NMOSD,” |
All press releases naming this drug 62 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Satralizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05679570 ↗ |
| Known as | Enspryng | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | RG6168 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | SA-237 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | Sapelizumab | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Known as | Satralizumab mwge | ChEMBL registry synonym — accepted as the source's own label CHEMBL3833307 ↗ |
| Action | Inhibit | “Satralizumab, an interleukin 6 receptor inhibitor” PMID 36724181 ↗ Dec 2022 |
| Modality | Monoclonal antibody | “Satralizumab is a humanized monoclonal antibody targeting the interleukin-6 receptor.” PMID 31774956 ↗ Nov 2019 |
| Route | Subcutaneous | “Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).” NCT02028884 ↗ |
| Target | IL6R | “Anti-IL-6 Receptor Antibody” NCT05679570 ↗ |