AbbVie Announces Late Breaking Data at AAN to Support Atogepant Long-Term Safety, Efficacy for Migraine Prevention

AbbVie today announced positive data on the long-term safety and tolerability of oral atogepant (Qulipta) for preventive treatment of chronic and episodic migraine. The findings come from an interim analysis of an ongoing phase 3 open-label 156-week extension study that includes participants from AbbVie’s phase 3 PROGRESS and ELEVATE clinical trials with a baseline monthly migraine day burden of 14.5 days.

Interim results. Among the extension trial cohort, 70% of participants achieved a 50% or greater reduction in monthly migraine days at study weeks 13 to 16, a decrease that remained consistent during the 48 weeks of open-label treatment. In other key interim findings, at weeks 13 to 16, the average improvement in number of monthly migraine days was 8.5 and similar improvements were reported for both monthly headache days and acute medication use days. All improvements were consistent over the 48 weeks.

The findings will be announced in full during an oral presentation at the American Academy of Neurology Annual Meeting Scientific Platform Session for Emerging Science, April 13-18, 2024, in Denver, CO.

"Migraine is a debilitating neurological disease that can have a significant impact on day-to-day life," 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 said in the announcement. "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 the ability of atogepant to reduce migraine days and acute medication use across the spectrum of the disease."

There were no new safety signals identified during the trial.

Study 3101-312-002, was designed to evaluate safety and tolerability in all participants who received at least one dose of atogepant 60 mg in the extension study (N = 595). Researchers evaluated efficacy by reviewing eDiary entries at weeks 13-16, 29-32 and 45-48. The modified intention-to-treat population included participants who received 1 or more doses of atogepant and had at least 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 improvement of 50% or more 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.

“We understand that migraine is a complex disease and AbbVie is steadfast in our commitment to alleviating the considerable burden facing migraine patients," Dawn Carlson, vice president, neuroscience development at AbbVie, said in the announcement. "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."

The global, randomized, double-blind, placebo-controlled trial ELEVATE study assessed the safety, tolerability, and efficacy of atogepant 60 mg once daily vs placebo for prevention of episodic migraine in adults who did not find relief with 2 to 4 classes of oral preventive treatments. The primary endpoint was the change from baseline in mean monthly migraine days (MMDs) across 12 weeks. Secondary endpoints included achievement of more than 50% reduction in MMDs, change from baseline in mean monthly headache days (MHDs), and change from baseline in acute medication use days across 12 weeks.

PROGRESS was a global, randomized, double-blind, placebo-controlled phase 3 trial assessing the efficacy, safety, and tolerability of atogepant for the preventive treatment of chronic migraine. Adults with a 1-year or longer history of chronic migraine were randomly assigned to receive oral atogepant 30 mg twice a day, oral atogepant 60 mg once a day, or placebo. The primary endpoint was change from baseline in MMDs across the 12-week treatment period. Key secondary endpoints included proportion of participants with at least a 50% reduction in MMDs, change from baseline in MHDs, and change from baseline in mean monthly acute medication use days across the 12-week treatment period.

Source: AbbVie announces late-breaking data at AAN supporting long-term safety and efficacy of atogepant (Qulipta) for preventive treatment of migraine. News release. AbbVie. April 12, 2024. Accessed April 12, 2024. https://news.abbvie.com/2024-04-12-AbbVie-Announces-Late-Breaking-Data-at-AAN-Supporting-Long-Term-Safety-and-Efficacy-of-Atogepant-QULIPTA-R-for-Preventive-Treatment-of-Migraine