AbbVie Inc. — Ubrelvy FDA Review (NDA211765, ORIG 1, 2019)
AbbVie Inc. · 2019 · FDA Review (openFDA) · company profile →
Report summary
The FDA clinical review recommends approval of Ubrogepant (UBRELVY) at 25 mg, 50 mg, and 100 mg doses for acute migraine treatment in adults. Two pivotal studies (MD-01, MD-02) demonstrated statistically significant efficacy for pain freedom and absence of most bothersome symptom at 2 hours compared to placebo, particularly with 50 mg and 100 mg doses. The 25 mg dose also showed significant pain freedom. While generally safe, common adverse events included nausea and somnolence. Subgroup analyses indicated reduced efficacy in patients over 65, males, and obese individuals. No significant cardiovascular or hepatotoxic signals were detected, but postmarketing requirements include deferred pediatric studies and enhanced pharmacovigilance for cardiovascular events.
Key findings — cited to the page
| Application Number | 211765 | · p.2 |
| Review Priority | Standard | · p.2 |
| Submission Date | 12/26/2018 | · p.2 |
| Received Date | 12/26/2018 | · p.2 |
| PDUFA Goal Date | 12/26/2019 | · p.2 |
| Review Completion Date | 12/19/2019 | · p.2 |
| Established/Proper Name | Ubrogepant | · p.2 |
| Proposed Trade Name | Ubrelvy | · p.2 |
| Applicant | Allergan Sales, LLC | · p.2 |
| Dosage Form | Tablet | · p.2 |
| Applicant Proposed Dosing Regimen | 50 mg or 100 mg orally; a second dose may be administered at least 2 hours after the initial dose; maximum 200 mg daily | · p.2 |
| Application Type | NDA | · p.2 |
Source: AbbVie 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 →