FDA accepts AbbVie's NDA for atogepant for the preventive treatment of migraine.- AbbVie

AbbVie announced that the 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. 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 III ADVANCE study, the pivotal Phase IIb/III study, and the Phase III long-term safety study.