FDA Approves Atogepant for Preventive Treatment of Episodic Migraine 

The Food and Drug Administration (FDA) approved atogepant (Qulipta; AbbVie, Chicago, IL) for the preventive treatment of episodic migraine in adults. Individuals treated with 60 mg of atogepant had a 4.2-day reduction in monthly migraine days (MMD) from baseline of 7.8. Approximately twice as many people who took atogepant compared with placebo had 50% to 100% reduction in migraine (56%-61% vs 29%; P<.001).

“This approval reflects a broader shift in the treatment and management paradigm for the migraine community. Qulipta 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," said Peter J. Goadsby, MD, PhD, DSc, neurologist and professor at University of California, Los Angeles, and King’s College, London, who earned the prestigious Brain Prize in 2021 for his revolutionary research about CGRP’s role in migraine attacks and coauthored the ADVANCE study. 
 
“I’m particularly encouraged by the convenience of the oral daily use of Qulipta, its rapid onset of significant efficacy, and its safety and tolerability as well as its high patient response rates. This is a milestone in preventive migraine treatment that I hope will help many patients for years to come,” Goadsby said.

The approval is based on the data the pivotal phase 3 multicenter randomized double-blind placebo-controlled parallel-group ADVANCE trial (NCT03777059) during a 12-week period. Atogepant is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist developed migraine treatment. All atogepant dose groups demonstrated statistically significant reductions in mean monthly migraine days compared with placebo. 

Adverse events that occurred with atogepant vs placebo included constipation (6% vs 1%), decreased appetite (1%-2% vs <1%), fatigue/somnolence (4%-6% vs 3%), and nausea (5%-9% vs 3%). Discontinuation due to adverse events was low and occurred because of constipation (0.5%), fatigue/somnolence (0.5%), or nausea (0.5%).