AbbVie Inc. — Aquipta EMA EPAR public assessment report (EMEA/H/C/005871, 2023)
AbbVie Inc. · 2023 · EMA EPAR public assessment report · company profile →
Report summary
The European Medicines Agency (EMA) granted marketing authorization for AbbVie's Aquipta (atogepant) for adult migraine prophylaxis. The assessment confirmed atogepant's quality, non-clinical safety (non-genotoxic, non-carcinogenic), and pharmacokinetic profile, including dose proportionality and drug interactions. Clinical trials demonstrated significant reductions in monthly migraine days, headache days, and acute medication use in both episodic and chronic migraine, with an early and sustained effect. Common adverse events included nausea, constipation, and fatigue. While generally favorable, continued monitoring for hepatic safety is recommended due to post-marketing reports of liver injury.
Key findings — cited to the page
| Atogepant pKa1 | 2.2 | Aquipta · p.12 |
| Atogepant partition coefficient (LogP) | 2.4 | Aquipta · p.12 |
| CHMP positive opinion for marketing authorisation | 22 June 2023 | Aquipta · p.9 |
| Atogepant tablet strength | 60 mg | Aquipta · p.11 |
| Indication for Aquipta | prophylaxis of migraine in adults who have at least 4 migraine days per month | Aquipta · p.7 |
| Atogepant molecular weight (monohydrate form) | 621.544 g/mol | Aquipta · p.11 |
| Duration of migraine attacks if untreated or unsuccessfully treated | 4 to 72 hours | · p.9 |
| Chronic migraine definition: headache days per month | 15 or more days per month | · p.10 |
| Chronic migraine definition: migraine headache days per month | at least 8 days per month | · p.10 |
| Atogepant tablet strength | 10 mg | Aquipta · p.11 |
| Subjects received atogepant in PCS | 1837 | · p.95 |
| Atogepant pKa2 | 10.2 | Aquipta · p.12 |
Source: AbbVie 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 →