Drugs / Fremanezumab
Fremanezumab
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed migraine disorder 4 milestones | |||||
| Filed | Japan (PMDA) | AJOVY | migraine disorder | 2020-07-29 | “an application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for Teva's fremanezumab.” otsuka.co.jp ↗ |
| Filed | EU (EMA) | — | migraine disorder | 2018-02-02 | “today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab” tevapharm.com ↗ |
| Filed | US (FDA) | — | migraine disorder | 2017-12-18 | “today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab” tevapharm.com ↗ “BLA for fremanezumab that Teva submitted to the U.S. Food and Drug Administration (FDA) in October.” tevapharm.com ↗ |
| Filed | US (FDA) | — | migraine disorder | 2017-10-17 | “today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab” tevapharm.com ↗ |
| Filed migraine with aura 1 milestone | |||||
| Filed | US (FDA) | AJOVY | migraine with aura | 2025-04-07 | “FDA has accepted its supplemental Biologics License Application (sBLA) for AJOVY® (fremanezumab-vfrm) to expand the indication to include the prevention of episodic migraine” tevapharm.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (2) | US (FDA) | AJOVY | — | 2020-01-27 – 2025-08-05 | fda.gov ↗ |
| Approved | EU (EMA) | Ajovy | — | 2019-03-28 | europa.eu ↗ |
| Approved | US (FDA) | AJOVY | — | 2018-09-14 | fda.gov ↗ |
Trials 31
News releases announcing trial results or a regulatory action · 59
| Date | Issuer | Release |
|---|---|---|
| 2026-02-04 | Teva Canada | Regulatory Teva Canada Announces Approval of Expanded Indication of PrAJOVY® (fremanezumab solution for subcutaneous injection), the First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine tevacanada.com ↗
Health Canada approves Pr AJOVY ® ( fremanezumab solution for subcutaneous injection) for the prevention of episodic migraine (fewer than 15 migraine days per month) in pediatric patients aged 6 to 17 years and weighing at least 45 kg . |
| 2026-01-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results AJOVY® (fremanezumab-vfrm) Significantly Reduced Monthly Migraine and Headache Days in Children and Adolescents with Episodic Migraine Compared to Placebo in the SPACE Trial; Results Published in New England Journal of Medicine tevapharm.com ↗
Results from the SPACE trial found AJOVY significantly reduced monthly migraine days and monthly headache days versus placebo over a 12-week period in pediatric patients with episodic migraine. |
| 2025-08-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Approves Expanded Indication for AJOVY® (fremanezumab-vfrm), The First Anti-CGRP Preventive Treatment for Pediatric Episodic Migraine tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced today that the U.S. Food and Drug Administration (FDA) has approved AJOVY for the preventive treatment of episodic migraine in children and adolescent patients aged 6-17 years who weigh 45 kilograms (99 pounds) or more. |
| 2025-06-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Final Data from Teva’s PEARL Real-World Study Reinforce the Long-term Effectiveness of AJOVY® (fremanezumab) for the Prevention of Chronic and Episodic Migraine tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the final analysis of the pan-European PEARL Phase 4 migraine prevention study showed that AJOVY (fremanezumab), an anti-calcitonin gene-related peptide (CGRP) monoclonal antibody, delivered sustained effectiveness over a two-year period in reducing frequency, duration and severity of migraine attacks in patients with chronic and episodic migraine. |
| 2025-04-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Filing Acceptance for AJOVY® (fremanezumab) in Pediatric Episodic Migraine Prevention tevapharm.com ↗ |
| 2024-12-04 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Positive Efficacy and Safety Data of AJOVY® (fremanezumab) for the Prevention of Episodic Migraine in Children and Adolescents from Phase 3 SPACE Trial tevapharm.com ↗
The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favourable safety profile1 consistent with that observed in the adult population. |
| 2024-07-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces First Phase 3 Evidence of Efficacy and Safety of an Anti-CGRP Monoclonal Antibody in Children in AJOVY® (fremanezumab) SPACE Trial for Prevention of Episodic Migraine tevapharm.com ↗
The trial met its primary end point with AJOVY (fremanezumab) achieving a statistically significant superior efficacy over 12 weeks of treatment compared to placebo. |
| 2024-06-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses tevapharm.com ↗
Over 40% of patients experienced a rapid worsening of their migraine (>=50% increase in MMD) at Months 1 and 2 post-cessation. |
| 2024-04-11 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Confirms Efficacy and Safety of AJOVY® (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China tevapharm.com ↗
Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients. |
| 2023-12-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Post Hoc Phase 3 Data Analysis Shows AJOVY® (fremanezumab) Reduced Migraine Attacks in Adults with Migraine and Co-morbid Obesity tevapharm.com ↗
AJOVY® (fremanezumab) efficacy and safety demonstrated in migraine patients with obesity in post hoc analysis of HALO-LTS1 and FOCUS2 phase 3 studies |
| 2023-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Phase IV UNITE Study Shows AJOVY® (fremanezumab) Reduced Migraine Attacks and Depression Symptoms in Migraine Sufferers with Major Depressive Disorder tevapharm.com ↗ |
| 2023-06-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva’s 3rd interim analysis of PEARL real-world study on AJOVY® (fremanezumab) reveals sustained long-term effectiveness in reducing frequency, duration and severity of attacks in patients with chronic and episodic migraine tevapharm.com ↗
The data from the 3rd interim analysis2 reveals that almost 60% of patients achieved a ≥50% reduction in monthly migraine days from baseline for migraine prevention, with sustained improvement in disability scores and acute medication use observed over 12 months. |
| 2023-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present Data at the 2023 American Headache Society Annual Scientific Meeting Demonstrating AJOVY® (fremanezumab-vfrm) Injection Significantly Reduced Migraine and Depression Symptoms in Patients tevapharm.com ↗
Results showed that treatment with AJOVY was associated with statistically significant reductions in migraine days as well as reductions in symptoms of depression (HAMD-17 and PHQ-9 scores) over 12 weeks in patients with migraine and major depressive disorder. |
| 2022-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Studies Show Effectiveness of AJOVY®▼ (fremanezumab) for Treatment of Migraine in Patients With Co-morbid Depression tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. today announces the results of two studies1,2 presented at the Migraine Trust International Symposium (MTIS) in London, UK, which demonstrate the efficacy of AJOVY▼ (fremanezumab) in migraine patients who also experience depression or anxiety. |
| 2022-06-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Promising Interim Results From Its Study PEARL, About the Impact of AJOVY® (fremanezumab) tevapharm.com ↗
These findings show that 54.7% of patients in the study had their monthly-migraine-days reduced by 50% or more, over the six-month period from the start of treatment. |
| 2022-06-15 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Obtains Approval in Japan for Auto-Injector Dosage Form for AJOVY Subcutaneous Injection 225 mg for Preventive Treatment of Migraine® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has received regulatory approval in Japan on June for an additional dosage form, auto-injector, for AJOVY Subcutaneous Injection 225 mg (generic name is fremanezumab). |
| 2022-06-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Real-World Data Evaluating AJOVY® (fremanezumab-vfrm) Injection Use in Patients With Migraine Presented at 2022 American Headache Society Annual Meeting tevapharm.com ↗
The data showing a reduction in monthly migraine days with the treatment combination were presented as a late-breaking poster during the 2022 American Headache Society (AHS) Annual Meeting held June 9-12, 2022, in Denver, Colorado. |
| 2021-09-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present 8 Abstracts on AJOVY® (fremanezumab-vfrm) Injection and Hold Symposium on Healthcare Disparities at WCN tevapharm.com ↗
Extension analyses observed patients taking AJOVY experienced a reduction in migraine and headache days and evaluated disability and health-related quality of life |
| 2021-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Late-Breaking Data at the International Headache Society & European Headache Federation Joint Congress 2021 Showed AJOVY® (fremanezumab-vfrm) Injection Reduced More Monthly Migraine Days in a Network Meta-Analysis Study with Atogepant and Rimegepant tevapharm.com ↗ |
| 2021-07-08 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Files Application in Japan for Approval of Auto-Injector Dosage Form for AJOVY Subcutaneous Injection 225 mg for Preventive Treatment of Migraine® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that it has applied to Japan's Ministry of Health, Labour and Welfare for an additional dosage form, auto-injector, for AJOVY Subcutaneous Injection 225 mg (generic name is fremanezumab). |
| 2021-06-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory AJOVY Subcutaneous Injection 225 mg Syringe, as a Preventive Treatment of Migraine, Granted Approval in Japan® otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that AJOVY Subcutaneous Injection 225 mg Syringe (generic name is fremanezumab) has received manufacturing and marketing approval in Japan for the indication of preventive treatment of migraine in adult patients. |
| 2021-06-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan. |
| 2021-06-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Data Supporting the Safety and Efficacy Profile of AJOVY® (fremanezumab) Shared at 7th European Academy of Neurology Congress tevapharm.com ↗
These new data offer the neurology prescribing community added confidence and further reassurance that any CV risks associated with fremanezumab use are minimal, particularly in relation to concerning issues such as hypertension. |
| 2021-06-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Clinical and Real-World Data Evaluating Efficacy of AJOVY® (fremanezumab-vfrm) Injection Presented at 2021 American Headache Society (AHS) Annual Meeting tevapharm.com ↗
We’re pleased to see the data presented at AHS is examining subgroups of patients who may experience fewer migraine days with AJOVY. |
| 2021-02-26 | Teva Branded Pharmaceutical Products R&D, Inc. | Results New Study Published in Cephalalgia Identifies Mechanistic Differences Among CGRP Migraine Treatments tevapharm.com ↗
This study demonstrated marked differences in the mechanism of blocking the calcitonin gene-related peptide (CGRP) ligand versus the CGRP receptor. |
| 2020-10-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces New Analysis of Consistency in Migraine Days Over the Course of a Dosing Regimen for AJOVY® (fremanezumab-vfrm) Injection Published in Headache tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from a post hoc analysis of a long-term, open-label extension study assessing migraine days at the beginning and end of quarterly and monthly dosing intervals of AJOVY® (fremanezumab-vfrm) injection. |
| 2020-09-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results First Long-Term Data on the use of AJOVY® (fremanezumab-vfrm) Injection in Patients with Migraine Published in Neurology tevapharm.com ↗
We are pleased to publish these results, which add to the growing body of knowledge on AJOVY and give us further insight into the potential for AJOVY to improve clinical outcomes with both quarterly and monthly dosing regimens. |
| 2020-07-29 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Otsuka Filed Application in Japan for Approval of Fremanezumab as a Prophylactic Treatment for Migraine otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) announces that an application has been submitted to the Pharmaceuticals and Medical Devices Agency in Japan to seek manufacturing and marketing approval for Teva's fremanezumab. |
| 2020-07-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces New Drug Application Filing in Japan for AJOVY® (fremanezumab) Injection tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced Otsuka Pharmaceutical Co., Ltd. has submitted an application to the Pharmaceuticals and Medical Devices Agency of Japan to obtain manufacturing and marketing approval in Japan for AJOVY® (fremanezumab) injection for the preventive treatment of migraine. |
| 2020-06-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Analyses Examining Changes in Migraine Disability Outcome Measurements with AJOVY® (fremanezumab-vfrm) Injection tevapharm.com ↗
An additional analysis of pooled results from three AJOVY Phase III trials (FOCUS, HALO-Episodic Migraine, HALO-Chronic Migraine) examined headache- and migraine-related disability based on guidelines set forth by the American Headache Society (AHS). |
| 2020-05-25 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presented New Data at the European Academy of Neurology Congress Evaluating the AJOVY® (fremanezumab) Experience in Populations with Difficult-to-Treat Migraine tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) presented a wide range of important new data on AJOVY® (fremanezumab) and the societal and economic impact of migraine in Europe at the 6th Congress of the European Academy of Neurology (EAN). |
| 2020-03-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Positive Recommendation by NICE for first anti-CGRP migraine therapy: AJOVY®▼ (fremanezumab) tevapharm.com ↗
NICE recommends AJOVY® for chronic migraine patients who have not responded to at least three prior preventive drug treatments. |
| 2020-02-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Top-Line Results from AJOVY® (fremanezumab) Clinical Trials in Japan tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive results from two Phase 2/3 trials evaluating AJOVY® (fremanezumab) in patients in Japan. |
| 2020-01-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of AJOVY® (fremanezumab-vfrm) Injection Autoinjector tevapharm.com ↗
Teva Pharmaceuticals USA, Inc. an affiliate ofTeva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the Food and Drug Administration (FDA) has approved an autoinjector device for AJOVY® (fremanezumab-vfrm) injection. |
| 2020-01-27 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Results Otsuka announces positive top-line results from clinical trials in Japan offremanezumab as a prophylactic treatment for migraine otsuka.co.jp ↗
Preliminary trial results indicated that primary endpoints were achieved with statistical significance versus placebo for subjects with chronic migraine and episodic migraine, respectively. |
| 2019-08-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Fremanezumab Data in The Lancet Demonstrate Clinically Meaningful Reduction in Monthly Migraine Days Versus Placebo for Patients with Difficult-To-Treat Migraine tevapharm.com ↗
The study found fremanezumab was superior versus placebo across all primary and secondary endpoints. |
| 2019-07-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Positive Results Showing Improvement in Disability and Quality of Life from the Phase IIIb FOCUS study of Fremanezumab in Adults with Migraine tevapharm.com ↗
Reductions from baseline in the monthly average number of migraine days during the 12-week treatment period were significantly greater with both fremanezumab regimens versus placebo in this subset of patients. |
| 2019-05-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Long-Term Data on Efficacy and Safety of Fremanezumab at 2019 American Academy of Neurology Annual Meeting tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced results from new long-term analyses of the efficacy and safety of fremanezumab, being presented at the 71st Annual Meeting of the American Academy of Neurology (AAN) in Philadelphia from May 4-10, 2019. |
| 2019-04-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Update on Fremanezumab Clinical Development for use in Episodic Cluster Headache tevapharm.com ↗
As a result of the above, Teva is discontinuing the ENFORCE Phase III clinical trial program, which also includes a long-term safety study. |
| 2019-04-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva’s AJOVY® Receives EU Approval Offering Patients the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Prophylaxis of Migraine in Adults tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Commission (EC) has granted the Marketing Authorization for AJOVY(fremanezumab) 225 mg solution for injection in pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month. |
| 2019-02-01 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives Positive Committee for Medicinal Products for Human Use (CHMP) Opinion for AJOVY® (fremanezumab) for the Prophylaxis of Migraine in Adults tevapharm.com ↗
We are very pleased to report a positive opinion by the CHMP, |
| 2018-12-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Topline Phase IIIb Results with Fremanezumab in Adults with Migraine Who Did Not Respond to Multiple Classes of Preventive Treatments tevapharm.com ↗ |
| 2018-09-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces U.S. Approval of AJOVY™ (fremanezumab-vfrm) Injection, the First and Only Anti-CGRP Treatment with Both Quarterly and Monthly Dosing for the Preventive Treatment of Migraine in Adults tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) todayannounced that the U.S. Food and Drug Administration (FDA) has approvedAJOVYTM (fremanezumab-vfrm) injection for the preventivetreatment of migraine in adults. |
| 2018-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Provides Update on Clinical Trial of Fremanezumab for Use in Chronic Cluster Headache tevapharm.com ↗
A pre-specified futility analysis of the chronic cluster headache study revealed that the primary endpoint of mean change from baseline in the monthly average number of cluster headache attacks during the 12-week treatment period is unlikely to be met. |
| 2018-05-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Confirms September PDUFA Date for Fremanezumab tevapharm.com ↗
The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018. |
| 2018-05-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Publication of Phase III Trial Data of Fremanezumab for the Preventive Treatment of Episodic Migraine in the Journal of the American Medical Association tevapharm.com ↗
The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens: |
| 2018-02-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for fremanezumab, an anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of episodic and chronic migraine in adults. |
| 2017-12-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Accepts Biologics License Application for Fremanezumab with Priority Review for Prevention of Migraine and Grants Fast Track Designation for Cluster Headache Development Program tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. |
| 2017-11-29 | Teva Branded Pharmaceutical Products R&D, Inc. | Results The New England Journal of Medicine Publishes Data from Pivotal Phase III Trial of Fremanezumab for the Preventive Treatment of Chronic Migraine tevapharm.com ↗
These data were published online today by the New England Journal of Medicine (NEJM) and will appear in a subsequent print issue. |
| 2017-10-17 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for the preventive treatment of migraine. |
| 2017-09-09 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Showcases Data Demonstrating Potential of Fremanezumab to Address Significant Unmet Need in Patients with Chronic and Episodic Migraine tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) has presented new data evaluating fremanezumab, an investigational treatment for the prevention of migraine, at the 18th Congress of the International Headache Society (IHC) in Vancouver, Canada. |
| 2017-06-07 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva's Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced positive results from the second Phase III HALO study of fremanezumab (TEV-48125), an investigational treatment for the prevention of migraine. |
| 2017-05-31 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Results for Phase III Study of Fremanezumab for the Prevention of Chronic Migraine tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced positive results from a Phase III HALO study of fremanezumab, an investigational treatment for the prevention of migraine. |
| 2015-09-30 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Important New Data from Teva's TEV-48125 Phase 2B Migraine Program Published in Lancet Neurology in Back-to-Back Articles tevapharm.com ↗
The Phase 2b clinical development program consistently met all primary and secondary efficacy and safety endpoints for TEV-48125 in 564 patients and across multiple doses. |
| 2015-06-24 | Nxera Pharma UK Limited | Results Download the presentation nxera.life ↗
Efficacy demonstrated in chronic migraine prophylaxis with TEV-48125 and ALD403 |
| 2015-06-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva to Present New Findings at the American Headache Society (AHS) Meeting – Analysis of Migraine Phase IIb Studies Provides Novel Insights into TEV-48125 Efficacy and Safety in Both Episodic & Chronic Migraine tevapharm.com ↗
TEV-48125 is the first investigational treatment to meet all efficacy endpoints in trials of both chronic and episodic migraine and across multiple doses |
| 2015-05-14 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents Further Data from Phase IIb with TEV-48125 in Chronic Migraine at the International Headache Society Congress (IHC): Efficacy and Safety Results at All Doses and Endpoints Present Robust Case for Progression to Phase III tevapharm.com ↗
Both assessed doses of TEV-48125 (loading of 675 followed by monthly injections of 225 mg or 900 mg), were significantly superior to placebo in reducing, relative to baseline, the number of hours with headache (primary endpoint - p < 0.05 and p < 0.01). |
| 2015-03-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva’s TEV-48125 Meets Primary and Secondary Endpoints in Episodic Migraine Study, Demonstrating Treatment Concept After a Single Dose tevapharm.com ↗
Initial analysis of results demonstrated that both doses of TEV-48125 met primary and secondary endpoints achieving significant reductions in mean monthly migraine days and monthly headache days relative to baseline. |
| 2015-02-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study Meeting Primary and Secondary Endpoints tevapharm.com ↗
Results demonstrated that both tested doses of TEV-48125 achieved the primary and secondary efficacy endpoints of the study at one and three months. |
All press releases naming this drug 85 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 38 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Fremanezumab | “Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously” NCT07071506 ↗ |
| Known as | AJOVY | “Assessing the Safety and Efficacy of Utilizing CGRPmAb Fremanezumab (Ajovy) in Chronic Migraine Patients Currently on Monotherapy OnabotulinumtoxinA (Botox).” NCT05724771 ↗4“This study is being conducted to evaluate the efficacy and safety of AJOVY (fremanezumab-vfrm) on interictal migraine related burden in adults.” NCT04461795 ↗ “Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home.” NCT04693533 ↗ “Standard dose of Fremanezumab, 225 mg (Ajovy) injected subcutaneously” NCT07071506 ↗ |
| Known as | Fremanezumab-Vfrm | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04547179 ↗ |
| Known as | LBR-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02025556 ↗ |
| Known as | PF-04472429 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297756 ↗ |
| Known as | RN-307 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297756 ↗ |
| Known as | TEV-48125 | “Fremanezumab (formerly TEV-48125) is a monoclonal antibody directed against calcitonin-gene-related peptide (CGRP), a validated target for migraine preventive therapy.” PMID 28862758 ↗ Sep 20176“The purpose of the current study is to evaluate the efficacy and safety of Fremanezumab (TEV-48125), in the prevention of CCH in adult participants.” NCT02964338 ↗ “A Safety Evaluation Trial of TEV-48125 Self-administered in Migraine Patients” NCT04355117 ↗ |
| Action | Inhibit | “Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection” NCT04693533 ↗ |
| Modality | Monoclonal antibody | “a selective monoclonal CGRP ligand antibody” PMID 30450545 ↗ Nov 2018 |
| Route | Intravenous | “Administered Intravenously” NCT01991509 ↗ |