AbbVie announces ELEVATE study meets all primary, secondary endpoints

AbbVie announced data from its Phase 3 ELEVATE study, evaluating atogepant for the preventive treatment of episodic migraine in people who had previously failed two to four classes of oral preventive medications. The results of the study demonstrated adult patients in the atogepant 60 mg once daily, or QD, arm experienced a decrease of 4.20 days in their mean monthly migraine days, or MMDs, across the 12-week treatment period, which was statistically significantly greater than the 1.85 day reduction observed in the placebo arm. The data will be presented during the Emerging Science session on Tuesday, April 25, at the 2023 American Academy of Neurology, or AAN, annual meeting taking place in Boston, Massachusetts. 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 treatment-emergent adverse events included constipation, COVID-19, nausea, and nasopharyngitis.