AbbVie (NYSE: ABBV) shares were much lower Friday, on the announcement of an interim analysis of an ongoing Phase 3, 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."
Test results showed 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. Seventy percent of subjects achieved ≥50% reduction in monthly migraine days at Weeks 13-16 and this was consistent during the 48 weeks of open-label treatment.
ABBV shares gave up $2.96, or 1.8%, to $163.01.
