AbbVie Inc. — Atogepant FDA Review (NDA215206, ORIG 1, 2021)
AbbVie Inc. · 2021 · FDA Review (openFDA) · company profile →
Report summary
The FDA review of AbbVie's atogepant (Qulipta) for episodic migraine prevention in adults confirmed its efficacy in reducing monthly migraine days across various doses in two key trials (CGP-MD-01 and 3101-301-002). While generally safe, the review addressed potential safety concerns including hepatotoxicity, elevated CPK, and ischemic vascular risk. Gastrointestinal issues like constipation and nausea were common adverse events. Toxicology studies, including carcinogenicity and reproductive toxicity, were also evaluated. Pharmacokinetic analyses showed most demographic factors do not significantly impact atogepant's PK. The FDA concluded that benefits outweigh risks with appropriate labeling and postmarketing surveillance, finding no significant liver toxicity threatening approval.
Key findings — cited to the page
| Patients with adverse events leading to discontinuation - Irritability | 1 n | · p.199 |
| Duration of treatment | 12 weeks | CGP-MD-01 · p.28 |
| Indication | preventive treatment of episodic migraine (EM) in adults | atogepant · p.18 |
| Rate of transaminase elevations over 3 times ULN | 1% percent | atogepant · p.19 |
| Applicant | Abbvie, Inc | Qulipta (atogepant) · p.2 |
| Approved dosage | 10 mg, 30 mg, 60 mg | Qulipta (atogepant) · p.2 |
| PDUFA goal date | 9/28/2021 | Qulipta (atogepant) · p.2 |
| Dosage form(s)/formulation(s) | 10 mg, 30 mg, and 60 mg | Qulipta (atogepant) · p.2 |
| Dosing regimen | One tablet daily | Qulipta (atogepant) · p.2 |
| Application type | NDA | Qulipta (atogepant) · p.2 |
| Regulatory action | Approval | Qulipta (atogepant) · p.2 |
| Number of patients treated | 825 | CGP-MD-01 · p.28 |
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 →