> ## 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.

# FDA OKs Qulipta Expanded Indication
- URL: https://www.fdaweb.com/fda-oks-qulipta-expanded-indication/
- Published: 2023-04-19T12:00:00.000Z
- Updated: 2026-09-14T18:26:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154257

FDA has approved a new indication for AbbVie’s Qulipta (atogepant) to include the preventive treatment of migraine in adults. A company [statement](https://www.prnewswire.com/news-releases/us-fda-approves-qulipta-atogepant-for-adults-with-chronic-migraine-301799554.html?ref=fdaweb.com) says Qulipta is the only oral calcitonin gene-related peptide receptor antagonist approved to prevent episodic and chronic migraine.

The expanded indication was based on the Phase 3 PROGRESS trial evaluating Qulipta 60 mg once daily in adult patients with chronic migraine. The trial met its primary endpoint of a statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The trial also recorded statistically significant improvements in six secondary endpoints, AbbVie says.