U.S. FDA Approves QULIPTA? (atogepant) for Adults With Chronic Migraine

發(fā)布時間： 2023-04-19 閱讀：478次

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April 17, 2023 -- AbbVie today announced that the U.S. Food and Drug Administration (FDA) has approved expanding the indication of QULIPTA? (atogepant) for the preventive treatment of migraine in adults. The approval makes QULIPTA the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. People living with chronic migraine experience headaches for 15 or more days per month, with at least eight of those days associated with migraine.

Migraine is a complex neurological disease with recurrent attacks that are often incapacitating and characterized by severe, throbbing headache pain as well as compounding associated symptoms like extreme sensitivity to light, sound or nausea. It is highly prevalent, affecting more than 1 billion people worldwide, including nearly 40 million people in the United States alone, and is the highest cause of disability worldwide for people under 50 years of age.

QULIPTA's expanded chronic migraine indication is based on the pivotal Phase 3 PROGRESS trial evaluating QULIPTA 60 mg once daily in adult patients with chronic migraine, which met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The average monthly migraine days (MMDs) for patients at baseline during the clinical trial was 19. The trial also demonstrated that treatment with QULIPTA resulted in statistically significant improvements in all six secondary endpoints. This includes key secondary endpoints that measured the proportion of patients that achieved at least a 50 percent reduction in mean monthly migraine days across the 12-week treatment period and improvements in function and reduction in activity impairment due to migraine. These efficacy results are consistent with those in the ADVANCE episodic migraine trial.