Teva Pharmaceutical Industries Limited — Ajovy FDA Review (BLA761089, ORIG 1, 2018)
Teva Pharmaceutical Industries Limited · 2018 · FDA Review (openFDA) · company profile →
Report summary
Teva's Ajovy (fremanezumab) was reviewed for migraine prevention, with the FDA recommending approval. Clinical trials (020, 021, 049, 050, 051) demonstrated statistically significant efficacy in reducing migraine days for both episodic and chronic migraine, with monthly and quarterly dosing. Safety evaluations covered a broad range of adverse events, including cardiovascular risks, suicidality, infections, and injection site reactions. While some SAEs occurred, most were deemed unrelated to the drug, and discontinuation rates were low. No clear cardiovascular signal or significant liver injury was found, though long-term cardiovascular safety remains a theoretical concern for post-marketing evaluation. The safety database was considered sufficient, with no issues precluding approval.
Key findings — cited to the page
| Episodic Migraine patients with Grade II disability (MIDAS score 6-10) | 24 % | · p.179 |
| Episodic Migraine patients with Grade IV disability (MIDAS score 21+) | 26 % | · p.179 |
| MIDAS score for Grade III disability | 11-20 | · p.177 |
| Chronic Migraine patients with Grade I disability (MIDAS score 0-5) | 5 % | · p.179 |
| Episodic Migraine patients with Grade III disability (MIDAS score 11-20) | 31 % | · p.179 |
| Chronic Migraine patients with Grade III disability (MIDAS score 11-20) | 5 % | · p.179 |
| MIDAS score for Grade I disability | 0-5 | · p.177 |
| MIDAS score for Grade II disability | 6-10 | · p.177 |
| MIDAS score for Grade IV disability | ≥21 | · p.177 |
| Episodic Migraine patients with Grade I disability (MIDAS score 0-5) | 18 % | · p.179 |
| Chronic Migraine patients with Grade II disability (MIDAS score 6-10) | 6 % | · p.179 |
| Chronic Migraine patients with Grade IV disability (MIDAS score 21+) | 84 % | · p.179 |
Source: Teva Pharmaceutical Industries Limited ↗ · License: US Government public domain. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →