FDA Accepts AbbVie's Atogepant US Review Application For Migraine
- The FDA has accepted for review AbbVie Inc's (NYSE: 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.
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