• The Phase 3 ELEVATE study demonstrated atogepant is effective and well-tolerated for the preventive treatment of episodic migraine in people who previously failed two to four classes of conventional oral medications used for prevention
• The trial met its primary and secondary endpoints with results showcasing a significant reduction in mean monthly migraine days for those with episodic migraine taking atogepant 60 mg once daily compared to placebo across a 12-week period
• Data will be presented as part of an oral and poster presentation during the AAN Scientific Platform Session for Emerging Science

"We understand that people living with migraine endure a chronic neurological disease and we are dedicated to providing them the best chance to live a life with less frequent migraines," said Dawn Carlson, vice president, neuroscience development, AbbVie. "The data presented at AAN underscores the important role of atogepant, not only as a treatment option for people living with episodic migraine but also for those whose previous treatments failed to help reduce the impact of migraine on their lives."

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."

Migraine is highly prevalent, affecting one billion people worldwide,¹ and is one of the highest causes of disability for people under 50 years of age.² Individuals with migraine experience frequent disabling migraine attacks, preventing them from performing daily activities and significantly affecting their quality of life.³ This debilitating disease imposes both a social and financial burden causing a significant burden for people living with migraine and healthcare systems.⁴

The U.S. Food and Drug Administration 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.