Teva — Ajovy EMA EPAR public assessment report (EMEA/H/C/004833, 2019)
Teva · 2019 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's public assessment report for Ajovy (fremanezumab) details its regulatory approval for episodic and chronic migraine prevention in adults. The report confirms acceptable quality and robust manufacturing of the IgG2 monoclonal antibody. Non-clinical studies showed no significant toxicity, carcinogenicity, or reproductive effects. Clinical pharmacology characterized its pharmacokinetics and low immunogenicity. Phase 2b and 3 trials demonstrated statistically significant, moderate reductions in headache and migraine days compared to placebo, with sustained efficacy over 15 months across various subgroups and dosing regimens. The safety profile indicated general tolerability, with common adverse events being injection site reactions. Rare hypersensitivity reactions, mild ophthalmic events, and no significant cardiovascular or liver toxicity concerns were noted. The CHMP recommended marketing authorization for Ajovy for adults experiencing at least 4 migraine days per month.
Key findings — cited to the page
| Number of patients randomized in Phase 2b study 021 (chronic migraine) | 264 | Study 021 · p.33 |
| Injection site pain (men, fremanezumab) | 16 % | fremanezumab migraine clinical development program · Global · p.83 |
| Indication applied for | treatment of episodic and chronic migraine in adults | AJOVY · p.6 |
| Number of Phase 2b studies for fremanezumab clinical efficacy | 2 | · p.26 |
| discontinuation due to adverse events (placebo) | 2 % | · p.97 |
| Fremanezumab heavy chain amino acid residues (des-Lys form) | 447 residues | Fremanezumab · p.11 |
| Fremanezumab molecular weight | 148 kDa | Fremanezumab · p.11 |
| Procedure start date | 1 February 2018 | · p.7 |
| Fremanezumab heavy chain amino acid residues | 448 residues | Fremanezumab · p.11 |
| Number of Phase 3 studies for fremanezumab clinical efficacy | 3 | · p.26 |
| Fremanezumab cysteine residues | 36 | Fremanezumab · p.11 |
| Cardiac disorders (fremanezumab, age >65) | 2 % | fremanezumab migraine clinical development program · Global · p.82 |
Source: Teva ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →