H Lundbeck A S — Vyepti EMA EPAR public assessment report (EMEA/H/C/005287, 2022)
H Lundbeck A S · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA's assessment of H. Lundbeck A/S's Vyepti (eptinezumab) for migraine prophylaxis led to a positive marketing authorization opinion. Vyepti, a CGRP monoclonal antibody, is indicated for adults experiencing at least 4 migraine days/month. The report details its manufacturing, quality control, and stability, confirming a 3-year shelf life. Non-clinical and clinical studies demonstrated its safety profile and efficacy in reducing monthly migraine days and improving responder rates in both episodic and chronic migraine, with standard doses of 100 mg or 300 mg IV every 12 weeks. Pharmacokinetic properties, immunogenicity, and exposure-response relationships were analyzed. While generally well-tolerated, common adverse events included nasopharyngitis and upper respiratory tract infections, with hypersensitivity reactions noted, particularly at higher doses. The safety profile was thoroughly evaluated, including adverse events of special interest and in special populations, with an ongoing risk management plan.
Key findings — cited to the page
| Subjects with Any Grade 3 or Higher TEAE (All Epti, OE pool) | 2.6 % | · p.127 |
| Grade 3 or higher TEAEs (Epti 100 mg subjects, OE pool) | 1.9 % | · p.126 |
| Subjects with Any Grade 3 or Higher TEAE (Epti 100 mg) | 1.7 % | · p.123 |
| Grade 3 or higher TEAEs (placebo subjects, OE pool) | 2.4 % | · p.126 |
| Grade 3 or higher TEAEs (all OE) | 2.6 % | · p.126 |
| Grade 3 or higher TEAEs (Epti 300 mg subjects, OE pool) | 3.5 % | · p.126 |
| Subjects with Any Grade 3 or Higher TEAE (All Epti Pivotal) | 2.2 % | · p.123 |
| Subjects with Any Grade 3 or Higher TEAE (Epti 300 mg) | 2.6 % | · p.123 |
| Subjects with Any Grade 3 or Higher TEAE (Placebo) | 3.1 % | · p.123 |
| Subjects with Any Grade 3 or Higher TEAE (All Epti Pivotal) | 2.2 % | · p.124 |
| Subjects with Any Grade 3 or Higher TEAE (Placebo) | 3.1 % | · p.124 |
| Subjects with Any Grade 3 or Higher TEAE (Placebo, OE pool) | 2.4 % | · p.127 |
Source: H Lundbeck A S ↗ · 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 →