Novartis AG — Aimovig EMA EPAR public assessment report (EMEA/H/C/004447, 2018)
Novartis AG · 2018 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for Aimovig (erenumab) for migraine prophylaxis in adults experiencing at least four migraine days per month. Novartis Europharm Ltd submitted the application in May 2017, receiving a positive opinion from the CHMP in May 2018. Aimovig, a first-in-class treatment, demonstrated statistically significant reductions in monthly migraine days and improved responder rates at 70 mg and 140 mg doses in both episodic and chronic migraine trials. While efficacy was comparable to existing treatments, Aimovig showed a favorable tolerability profile. The manufacturing process, quality control, and stability of the drug were deemed acceptable. Safety data indicated generally low rates of serious adverse events, with common side effects including injection site reactions and constipation. Concerns regarding long-term cardiovascular safety in high-risk patients were noted, necessitating further data.
Key findings — cited to the page
| Grade ≥4 post-baseline creatine kinase levels (AMG 334 70mg) | 0.3 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥4 post-baseline creatine kinase levels (AMG 334 140mg) | 0.9 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥4 post-baseline creatine kinase levels | 0.1 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥4 post-baseline creatine kinase levels (AMG 334 140mg) | 0.4 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥4 post-baseline creatine kinase levels | 0.4 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥4 post-baseline creatine kinase levels (AMG 334 70mg) | 0.6 % | AMG 334 (Aimovig) · p.81 |
| Grade ≥ 3 AEs (Pool C, 140 mg) | 5.5% | · p.76 |
| Grade ≥ 3 AEs (Pool A, 70 mg) | 3.4% | · p.73 |
| Grade ≥ 3 AEs (Pool C, 70 mg) | 8.1% | · p.76 |
| Exposure-adjusted incidence rate of Grade ≥ 3 AEs (Pool C, 70 mg) | 8.9 per 100 SY | · p.76 |
| Grade ≥ 3 AEs (Pool A, placebo) | 3.2% | · p.73 |
| Grade ≥ 3 AEs (Pool A, 140 mg) | 3.2% | · p.73 |
Source: Novartis AG ↗ · 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 →