Abstract Details

Atogepant is an oral calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine. ELEVATE and PROGRESS were phase 3, randomized, doubleblind, placebo-controlled trials evaluating atogepant for the preventive treatment of episodic migraine (EM) in participants with an inadequate response to 2–4 classes of conventional oral preventive treatment (ELEVATE), and for the preventive treatment of chronic migraine (CM) (PROGRESS).

Evaluate the long-term safety and efficacy of atogepant for the preventive treatment of migraine.

This interim analysis (September 14, 2023) of the open-label, 156-week, long-term safety extension study evaluated atogepant 60 mg once daily for the preventive treatment of EM or CM in participants who completed ELEVATE or PROGRESS, respectively. The long-term safety, tolerability, and efficacy of atogepant in participants completing Week 48 or early termination was evaluated. Efficacy was assessed during the first 48 weeks.

The safety population in this interim analysis included 595 participants (ELEVATE, n=270; PROGRESS, n=325). Mean duration of atogepant exposure was 496.5 days. Treatment-emergent adverse events (TEAEs) occurred in 79.0% of participants; most were mild/moderate and not related to atogepant. Common TEAEs (≥5%) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%). One death attributed to asphyxia by housefire was observed. Other serious TEAEs occurred in 5.5% of participants and were not related to atogepant. TEAEs leading to discontinuation occurred in 5.9% of participants. ALT/AST ≥3 x ULN occurred in 2 participants; none met Hy’s Law. Least square mean change from baseline in monthly migraine days was -5.5 (ELEVATE) and -10.9 (PROGRESS) at Weeks 13-16 and was sustained over 48 weeks. Similar outcomes were observed for monthly headache days and monthly acute medication use days.

The overall safety results were consistent with the known safety profile of atogepant. No new safety signals were identified. Improvements in efficacy outcomes were sustained over 48 weeks.