Pfizer Inc. — Nurtec FDA Review (NDA212728, ORIG 1, 2020)
Pfizer Inc. · 2020 · FDA Review (openFDA) · company profile →
Report summary
The FDA clinical review recommends approval of Pfizer's Nurtec (rimegepant 75 mg ODT) for acute migraine treatment. Three pivotal Phase 3 studies (301, 302, 303) consistently demonstrated statistically significant improvements over placebo in co-primary endpoints: pain freedom and absence of most bothersome symptom at two hours post-dosing. Efficacy was observed across various demographics, though effects were diminished in patients over 65 and males. The safety profile appears favorable, with no major serious toxicities or significant cardiovascular/hepatotoxicity signals. Common adverse events included gastrointestinal issues like nausea and dyspepsia. The safety database was deemed adequate, with no imbalance in suicidality signals. Further evaluation for patients with major cardiovascular disease is suggested.
Key findings — cited to the page
| Grade 1 or 2 CK elevations | 15.5 % | · p.93 |
| Grade 3 CK elevations | 0.2 % | · p.93 |
| Grade 4 CK elevations | 0.3 % | · p.93 |
| Priority Status | Priority | · p.2 |
| Application Type | NDA | · p.2 |
| Application Number | 212728 | · p.2 |
| Applicant | Biohaven | · p.2 |
| Received Date | 06/27/2019 | · p.2 |
| PDUFA Goal Date | 02/27/2020 | · p.2 |
| Review Completion Date | 02/26/2020 | · p.2 |
| Established/Proper Name | Rimegepant | · p.2 |
| Submit Date | 06/27/2019 | · p.2 |
Source: Pfizer Inc. ↗ · 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 →