U.S. FDA Accepts AbbVie's New Drug Application for Atogepant for the Preventive Treatment of Migraine
AbbVie Inc. (ABBV)
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Source: PR Newswire
NORTH CHICAGO, Ill., March 30, 2021 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for atogepant, an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. AbbVie anticipates a regulatory decision in late Q3 2021.Migraine is a complex, chronic disease with attacks that are often incapacitating and can include headache pain as well as neurologic and autonomic symptoms.3 Migraine symptoms and severity range widely among individuals.The NDA is supported by data from a robust clinical program evaluating the efficacy, safety and tolerability of orally administered atogepant in nearly 2,500 patients who experience 4-14 migraine days per month including but not limited to the pivotal Phase 3 ADVANCE study, the pivotal Phase 2b/3 study, and the Phase 3 long
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