AbbVie 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.

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. 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.

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.

"AbbVie has nearly 12 years of experience in treating chronic migraine, a debilitating disease. We know that no two migraine patients are alike, so it is important for health care providers to have a variety of treatment options," said Michael Severino, M.D., vice chairman and president, AbbVie. "These data and pending regulatory submissions solidify our commitment to our leading migraine portfolio to help the more than one billion people worldwide living with the migraine. We look forward to taking the next steps to potentially expand the use of atogepant in the United States to include the preventive treatment of chronic migraine in adults, and to working with regulatory agencies globally on additional submissions."