▎WuXiEdited by Kant Content Team

AbbVie today announced the interim analysis results of the Phase 3 clinical trial for its migraine therapy, Qulipta (atogepant). The extension study, which lasted 156 weeks, aimed to evaluate the long-term safety and tolerability of oral atogepant in preventing migraine attacks in patients with chronic or episodic migraines. The analysis showed,Atogepant demonstrated a favorable overall safety profile and reduced the number of days patients used acute medications for migraine attacks each month.

• During weeks 13-16, the average number of migraine days per month decreased by 8.5 days., and this trend remained stable over 48 weeks. Patients also experienced similar improvements in the number of headache days per month and the number of days per month of acute medication use.
• 70% of subjects experienced a ≥50% reduction in monthly migraine days by weeks 13-16.,and maintained this effect throughout the 48-week open-label treatment period.
• The overall safety results were consistent with the known safety profile of 60 mg atogepant, and no new safety signals were identified.
• The most common adverse events (≥5%) during treatment were COVID-19 (28.7%), nasopharyngitis (10.9%), and constipation (8.2%).

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Atogepant is an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist, specifically for the preventive treatment of migraine in adults.CGRP is a vasodilatory neuropeptide whose release levels significantly increase during migraine attacks and are positively correlated with the severity of headache. CGRP and its receptor are expressed in areas of the nervous system related to the pathogenesis of migraines. Studies have shown that selective CGRP receptor antagonists provide clinical benefits for the treatment of migraines. In September 2021, Atogepant was approved by the U.S. FDA for the preventive treatment of episodic migraines in adults and received approval last April.FDA ApprovalIts expanded indication application is for the prevention of chronic migraines.This approval makes atogepant the first orally administered CGRP receptor antagonist approved for the prevention of episodic and chronic migraine.

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References:

[1] AbbVie Announces Late-Breaking Data at AAN Supporting Long-Term Safety and Efficacy of Atogepant (QULIPTA®) for Preventive Treatment of Migraine. Retrieved April 12, 2024 from 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

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