Late-Breaking results from phase III trial of Qulipta for the preventive treatment of episodic migraine presented at the 2023 AAN Annual Meeting.-AbbVie

The results of the study demonstrated adult patients in the atogepant 60 mg once daily (QD) arm experienced a decrease of 4.20 days in their mean monthly migraine days (MMDs) across the 12-week treatment period, which was statistically significantly greater than the 1.85 day reduction observed in the placebo arm (p<0.0001). the data will be presented during the emerging science session on tuesday, april 25, at the 2023 american academy of neurology (aan) annual meeting taking place in boston, massachusetts.></0.0001).>

The ELEVATE study met all primary and secondary endpoints and demonstrated a statistically significant reduction in MMDs for those with episodic migraine taking atogepant 60 mg QD compared to placebo. The primary endpoint was the change from baseline in mean MMDs across 12 weeks and the secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in MMDs, and change from baseline in acute medication use days across 12 weeks.

A total of 309 participants were enrolled and of these participants, 56% had previously failed two classes of oral migraine preventive medications and 44% had previous failed three or more classes, having discontinued them due to concerns with efficacy or tolerability. The results demonstrated atogepant 60 mg QD was well tolerated and the safety results were consistent with the known safety profile of atogepant. The most commonly reported (?5% in any treatment arm) treatment-emergent adverse events (atogepant vs placebo, respectively) included constipation (10.3% vs 2.5%), COVID-19 (8.3% vs 9.6%), nausea (7.1% vs 3.2%), and nasopharyngitis (5.1% vs 7.6%).

"For those living with migraine, the path towards effective treatment can be a long and complex journey," said Prof. Patricia Pozo-Rosich, MD, PhD, Head of Neurology Section, Vall d'Hebron Hospital and Institute of Research, Spain. "The ELEVATE trial demonstrates atogepant as a once-daily oral treatment that can significantly reduce monthly migraine days across a lifelong disorder, allowing people to experience relief in their daily lives, including those who have previously been failed by other preventive migraine treatments."

The FDA recently approved Qulipta as the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist proven to prevent both episodic and chronic migraine in adults in the United States. AbbVie will continue to pursue regulatory submissions for atogepant across international markets throughout the year.