Expanded Indication Approval for Prevention of Chronic Migraine Requested for Atogepant 

Based on the data from the pivotal phase 3 PROGRESS trial (NCT03855137), a supplemental new drug application for prevention of chronic migraine has been submitted for atogepant (Qulipta; AbbVie, Chicago, IL).

In the PROGRESS trial, participants treated with atogepant had statistically significant reductions from baseline in mean monthly migraine days (MMD) compared with participants treated with placebo. In the modified intention to treat (mITT) population, individuals (n=755) treated with 60 mg atogepant once daily or 30 mg twice daily had 6.88 (P=.0009) and 7.46 (P<.0001) fewer MMD, respectively, vs 5.05 fewer MMD in those treated with placebo.

Use of atogepant vs placebo also significantly decreased the number of acute migraine treatments used per month over the 12-week trial period and improved function as measured with the Migraine Specific Quality of Life (MSQ) version 2.1 Role Function-Restrictive domain score at Week 12, which assesses how much migraine is impacting a person's daily, social, and work activities. The most common adverse events observed in participants were constipation and nausea.

Approval of this expanded indication would make atogepant the first in the -gepant class of migraine medications available for preventive treatment of both episodic and chronic migraine.