FDA accepts AbbVie's filing for atogepant for migraine prevention

The US Food and Drug Administration 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.

The drug’s developer, AbbVie (NYSE: ABBV), anticipates a regulatory decision in late third-quarter 2021. AbbVie gained rights to atogepant along with its $63 billion acquisition of Allergan, which completed in May last year.

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.