> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AbbVie NDA for Migraine Accepted for Review
- URL: https://www.fdaweb.com/abbvie-nda-for-migraine-accepted-for-review/
- Published: 2021-03-30T12:00:00.000Z
- Updated: 2026-09-14T16:52:49.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148994

FDA has accepted for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The company says it expects a regulatory decision late in the third quarter.

The submission is based on data from a pivotal Phase 3 study called ADVANCE, a pivotal Phase 2b/3 study, and a Phase 3 long-term safety study. In the Phase 3 ADVANCE study, all atogepant active treatment arms met their primary endpoint of a statistically significant reduction in mean monthly migraine days over a 12-week treatment period, AbbVie says. Also, the 30 and 60 mg doses met all six secondary endpoints with statistical significance, it says. The study results were [announced 7/2020](https://c212.net/c/link/?t=0&l=en&o=3110501-1&h=4166562535&u=https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-data-for-atogepant-in-migraine-prevention.htm&a=press+release&ref=fdaweb.com).