- Pivotal Phase 3 study evaluating atogepant in adult patients with chronic migraine meets primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period¹

- Study also demonstrates statistically significant improvements in all secondary endpoints¹

- Overall safety profile is consistent with safety findings observed in previous studies with an episodic migraine population¹

- Data from this study will support a submission to expand the use of atogepant to include preventive treatment of chronic migraine in the United States and additional submissions globally

- These results strengthen AbbVie's commitment to advancing its portfolio of medicines to help more people living with migraine

NORTH CHICAGO, Ill., March 10, 2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the Phase 3 PROGRESS trial evaluating atogepant (QULIPTA™ in the United States), an oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) for the preventive treatment of chronic migraine in adults, met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo, for both the 60 mg once daily (QD) and 30 mg twice daily (BID) doses, across the 12-week treatment period. The study also demonstrated that treatment with atogepant 60 mg QD and 30 mg BID resulted in statistically significant improvements in all secondary endpoints after adjustment for multiple comparisons.1

This Phase 3, global, randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy, safety, and tolerability of oral atogepant for the preventive treatment of chronic migraine, which is a debilitating neurological disease where patients experience headache occurring on 15 or more days per month for more than three months, which on at least eight days per month has features of migraine headache.2,3 A total of 778 patients with at least a one-year history of chronic migraine were randomized into one of three treatment groups to receive 60 mg QD of atogepant, 30 mg BID of atogepant, or placebo.2

Efficacy was analyzed using two slightly different definitions of the patient population based on regulatory agency feedback in the United States and European Union. The United States-focused, modified intent-to-treat (mITT) population included 755 patients with evaluable headache eDiary data collected during the double-blinded treatment period. The European Union-focused off-treatment hypothetical estimand (OTHE) population included 760 patients with evaluable headache eDiary data collected during the double-blind treatment period and the follow-up period.

Across the 12 weeks, based on the mITT population, patients in the atogepant 60 mg QD and 30 mg BID treatment arms of the study, experienced a decrease of 6.88 and 7.46 monthly migraine days, respectively, compared to patients in the placebo arm, who experienced a decrease of 5.05 monthly migraine days (60 mg QD vs. placebo, p=0.0009; 30 mg BID vs. placebo, p