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FDA Approves AbbVie’s Qulipta

September 30, 2021


AbbVie announced that FDA approved Qulipta (atogepant) for the preventive treatment of episodic migraines in adults on Sept. 28, 2021. According to a company press release, Qulipta is the first and only oral calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) specifically developed for preventative migraine treatment.

This approval follows a series of studies that tested nearly 2000 patients who experienced 4 to 14 migraine days per month. According to AbbVie, their pivotal Phase IIb/III study demonstrated that patients would experience a 50-100% reduction in monthly migraine days across 12 weeks.

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