AbbVie Inc. — Aquipta EMA EPAR variation assessment report (EMEA/H/C/005871, 2023)
AbbVie Inc. · 2023 · EMA EPAR variation assessment report · company profile →
Report summary
AbbVie's Aquipta (atogepant) received a Type II variation approval to expand its indication for the acute treatment of migraine in adults. This approval is based on interim results from the Phase 3 ECLIPSE study (M24-305), which demonstrated significant efficacy of atogepant 60 mg in achieving pain freedom and absence of most bothersome symptoms at 2 hours post-dose compared to placebo. Efficacy was consistent across multiple attacks and subgroups. The safety profile showed no new signals compared to its prophylactic use, with common adverse reactions including nausea, constipation, and fatigue. Ongoing pharmacovigilance studies will address long-term safety and use in specific populations. The CHMP recommended approval of this variation.
Key findings — cited to the page
| Daphnia sp. Reproduction Test NOEC (Daphnia magna) | 550 µg/L | · p.9 |
| migraine prevalence in men | 6% to 7% | United States, Europe · p.51 |
| Variation type | B.II.e.5.a.2 | · p.6 |
| Application type | Type II variation | AQUIPTA · p.6 |
| Application submission date | 6 November 2025 | AQUIPTA · p.6 |
| Variation type | C.I.6.a | · p.6 |
| migraine prevalence | 14% | Global · p.51 |
| Variation type | B.II.e.5.a.1 | · p.6 |
| Study duration | 24-week | ECLIPSE (M24-305) · Global · p.6 |
| Study phase | Phase 3 | ECLIPSE (M24-305) · Global · p.6 |
| Pack size addition | 7 tablets | AQUIPTA · p.6 |
| migraine prevalence in women | 16% to 18% | United States, Europe · p.51 |
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 →