Pfizer Inc. — Vydura EMA EPAR public assessment report (EMEA/H/C/005725, 2022)
Pfizer Inc. · 2022 · EMA EPAR public assessment report · company profile →
Report summary
The EMA assessed Vydura (rimegepant) for acute and prophylactic migraine treatment in adults. Rimegepant, a novel CGRP receptor antagonist, demonstrated modest but statistically significant efficacy in reducing pain and most bothersome symptoms in acute attacks, and decreasing monthly migraine days in prevention. Its quality, non-clinical safety, and pharmacokinetic profiles were thoroughly evaluated, showing high CGRP receptor affinity and selectivity, no reproductive toxicity, and no dose adjustments needed for mild to moderate renal/hepatic impairment. While nausea was the most common adverse event, rimegepant exhibited a favorable safety profile with no significant cardiovascular or hepatotoxicity concerns. The CHMP recommended marketing authorization, classifying it as a new active substance requiring additional monitoring.
Key findings — cited to the page
| Withdrawal symptoms (e.g. irritability) | 1/1693 | studies 201 and 305 · p.127 |
| Risk difference for pain freedom at 2 hours vs placebo | 7.59 | Study 303 · p.78 |
| Eligibility to centralised procedure agreed | 23 July 2020 | Vydura · Europe · p.7 |
| Placebo arm evaluable participants | 535 | Study 303 · p.78 |
| Pain freedom at 2 hours | 19.6 % | Study 303 · p.78 |
| Pain freedom at 2 hours (placebo) | 12.0 % | Study 303 · p.78 |
| Trial design | Phase 3, multicentre, randomised, double-blind, placebo-controlled, parallel study | Study 303 · p.78 |
| Rimegepant dose | 75 mg | Vydura · p.12 |
| Application submission date | 8 February 2021 | Vydura · Europe · p.7 |
| Total evaluable participants | 1072 | Study 303 · p.78 |
| CHMP Assessment report adoption date | 24 February 2022 | Vydura · Europe · p.1 |
| Rimegepant 75mg arm evaluable participants | 537 | Study 303 · p.78 |
Source: Pfizer Inc. ↗ · 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 →