Atogepant receives FDA approval for the preventive treatment of episodic migraine in adults

On September 28, 2021, the United States Food and Drug Administration (FDA) approved QULIPTATM (atogepant), a once-daily preventive treatment for episodic migraine in adults. Atogepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist developed for preventive treatment of migraine.

Atogepant will be available in 10 mg, 30 mg, and 60 mg tablets, all to be taken once daily. Lower doses are specifically recommended for patients also taking other medications that are cytochrome P3A4 (CYP3A4) inducers or organic anion transporting polypepetide (OATP) inhibitors.

Current American Headache Society president, Peter J. Goadsby, MD, PhD, DSc, FAHS, was quoted in the press release: “This approval reflects a broader shift in the treatment and management paradigm for the migraine community. [Atogepant] provides a simple oral treatment option specifically developed to prevent migraine attacks and target CGRP, which is believed to be crucially involved in migraine in many patients.”

Clinical Trial1,2

FDA approval was supported by the results of a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group ADVANCE trial of the efficacy, safety, and tolerability of atogepant 10 mg, 30 mg, and 60 mg doses.

The primary end point was the change from baseline in the mean number of migraine days per month across the 12 weeks. At week 12, all atogepant dose groups met the primary end point (P<0.001 for all comparisons with placebo) and saw >50% reduction in monthly migraine days from baseline. Patients treated with 60 mg across 12 weeks experienced a 4.2-day reduction from a baseline of 7.8 migraine days per month.

All doses were well tolerated in the ADVANCE trial and pivotal Phase 2b/3 clinical trial. Adverse reactions in both studies (incidence at least 2% and greater than placebo) included nausea (5-9%), constipation (6%), fatigue/somnolence (4-6%) and decreased appetite (1-2%).

See the full study published in the New England Journal of Medicine.

This article is notice of a new approval, not intended to be an endorsement of a particular product and/or treatment modality.

References: 1. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695-706. 2. QULIPTA™ (atogepant) [package insert]. North Chicago, Ill.: AbbVie Inc.; 2021.

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