Atogepant

Atogepant is a drug for which a Type II variation application was submitted on 6 November 2025, and approved on 11 August 2023. This variation included the addition of 2 and 7 tablet pack sizes. The primary efficacy endpoint for Europe was pain freedom at 2 hours after the double-blind (DB) dose for the first qualifying migraine attack. The key secondary efficacy endpoint was the absence of the most bothersome migraine-associated symptom (MBS) at 2 hours after the DB dose for the first qualifying migraine attack.

In a Phase 3 study, 1232 subjects received at least one dose of the DB study drug. Pain freedom at 2 hours post-dose was observed in 24.3% of subjects, while the absence of MBS at 2 hours was 43.7%. Sustained pain freedom 2-24 hours post-dose was 17.8%, and sustained pain freedom 2-48 hours post-dose was 16.6%. Acute rescue medication use within 24 hours after the first attack was 15.1%. Pain freedom at 2 hours post-dose for moderate baseline headache pain was 27.4%.

Regarding safety, 5.6% of subjects experienced at least one 48-hour treatment-emergent adverse event (TEAE) during the first migraine attack. Across the entire DB period, 27.3% of subjects experienced TEAEs, and 9.3% experienced at least one 48-hour TEAE. Nausea within 48 hours after treating any migraine attack was reported in 1.3% of subjects, and nasopharyngitis occurred in 3.8% of subjects during the entire DB period.