FDA to Review Atogepant for Prevention of Episodic Migraine

Officials with the FDA have accepted a New Drug Application (NDA) for AbbVie’s atogepant for the preventive treatment of episodic migraine in adults.

Atogepant is an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist. If approved, atogepant will be the first oral CGRP receptor specifically developed for the preventive treatment of migraine, according to AbbVie.

The NDA is supported by data from the clinical trial program evaluating the efficacy, safety, and tolerability of oral atogepant in approximately 2500 patients. Patients in the program experience 4 to 14 migraine days per month. The clinical program includes the phase 3 ADVANCE study, phase 2b/3 study, and the phase 3 long-term safety study.

The phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group trial included a total of 910 patients. Each patient was randomized to 1 of 4 treatment groups: 10 mg, 30 mg, or 60 mg of atogepant once daily, or a placebo. Efficacy analyses were based on the modified intent-to-treat (mITT) population of 873 patients.

The primary end point of the phase 3 ADVANCE study was change from baseline in mean monthly migraine days across the 12-week treatment period. According to the results, all active treatment arms of atogepant met their primary end point, and the 30 and 60 mg doses met all 6 secondary end points with statistical significance. Patients treated in the 10 mg, 30 mg, and 60 mg atogepant arms experienced a decrease of 3.69, 3.86, and 4.2 days, respectively, compared with patients in the placebo arm who experienced a decrease of 2.48 days (all dose groups vs placebo, P=<0.0001).

All doses were well tolerated. The most commonly reported adverse effects (AEs) included constipation, nausea, and upper respiratory tract infection. The majority of AEs were mild or moderate in severity and did not lead to discontinuation.

The phase 3 long-term safety study evaluated safety and tolerability of 60 mg oral atogepant administered daily over 52 weeks. The results of this study will be presented at the American Academy of Neurology 2021 Virtual Annual Meeting.

AbbVie anticipates a regulatory decision in late Q3 2021.

Reference

1. US FDA Accepts AbbVie’s New Drug Application for Atogepant for the Preventive Treatment of Migraine. News release. AbbVie; March 30, 2021. Accessed March 30, 2021. https://news.abbvie.com/news/press-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-preventive-treatment-migraine.htm