Late-breaking data presented at AAN supporting long-term safety and efficacy of atogepant (Qulipta) for preventive treatment of migraine – AbbVie

AbbVie announced an interim analysis of an ongoing Phase III, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine .

The overall long-term safety results were consistent with the known safety profile of atogepant in chronic and episodic migraine, and no new safety signals were identified. These results also support improvements in key efficacy outcomes, including reduction in monthly acute medication use days.

“Migraine is a debilitating neurological disease that can have a significant impact on day-to-day life,” said Sait Ashina, MD, assistant professor of neurology and anesthesia at Harvard Medical School, director of the Comprehensive Headache Center at Beth Israel Deaconess Medical Center in Boston, and lead author of the study. “As the first report of one-year atogepant data in patients with chronic migraine, this builds on the long-term observed safety and efficacy in the episodic migraine population and demonstrates atogepant’s ability to reduce migraine days and acute medication use across the spectrum of the disease.”

The extension study included participants who had enrolled in the Phase III PROGRESS and ELEVATE clinical trials with a baseline monthly migraine day burden of 14.5 days and completed these studies. Key findings from the interim analysis include : i. Monthly migraine days improved on average by 8.5 days at Weeks 13-16 and this was consistent over 48 weeks. Similar improvements were observed for monthly headache days and monthly acute medication use days. ii. Seventy percent of subjects achieved greater than 50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open-label treatment. iii. Overall safety results were consistent with the known safety profile of atogepant 60 mg, and no new safety signals were identified. iv. The most common treatment-emergent adverse events (greater than 5%) were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

“We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients,” said Dawn Carlson, vice president, neuroscience development, AbbVie. “Patients should accept nothing less than migraine freedom, and the long-term safety and efficacy shown in this interim analysis marks another step toward that goal.”

Atogepant, also known as Qulipta in the U.S. and Aquipta in the European Union (EU), is approved in 45 countries. It is an oral calcitonin gene-related peptide (CGRP) receptor antagonist proven to prevent both episodic and chronic migraine in adults.

About Study 3101-312-002 ; Study 3101-312-002 is an ongoing Phase III, multicenter, open-label 156-week extension study evaluating the long-term safety and tolerability of oral atogepant for the prevention of migraine in participants with chronic or episodic migraine. The primary objective was to evaluate safety and tolerability in all participants who received greater than 1 dose of study intervention in the extension study (N = 595). Efficacy was evaluated by eDiary at Weeks 13-16, 29-32 and 45-48. The modified intention-to-treat population included participants who received greater than 1 dose of atogepant and had greater than 1 evaluable post-baseline 4-week period of eDiary data (N=524). Pre-specified efficacy endpoints included in the late-breaking data included change from baseline in monthly migraine days, monthly headache days, monthly acute medication use days and the proportion of participants with greater than 50% improvement in monthly migraine days. The current interim analysis was performed after all study participants completed the efficacy data collection portion of the study at Week 52 or early termination. More information can be found on www.clinicaltrials.gov (NCT04686136).