FDA Accepts AbbVie's Atogepant US Review Application For Migraine

The FDA has accepted for review AbbVie Inc's ABBV marketing application seeking approval for Atogepant for the preventive treatment of migraine in adults who meet the criteria for episodic migraine.
The regulatory decision is expected in late Q3 2021.
Atogepant is an investigational orally administered calcitonin gene-related peptide (CGRP) receptor antagonist.
The NDA is supported by data from a 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 Phase 3 ADVANCE study, Phase 2b/3 study, and the Phase 3 long-term safety study.
Price Action: ABBV shares are up 0.16% at $106.9 in premarket trading on the last check Tuesday.