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# AbbVie to Submit Qulipta sNDA to Expand Indication
- URL: https://www.fdaweb.com/abbvie-to-submit-qulipta-snda-to-expand-indication/
- Published: 2022-03-10T12:00:00.000Z
- Updated: 2026-09-14T17:35:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151340

AbbVie says that based on the results of the Phase 3 PROGRESS trial it will submit an sNDA to FDA to expand the indication for its Qulipta (atogepant) for the preventive treatment of chronic migraine. The company [says](https://news.abbvie.com/news/press-releases/abbvie-announces-positive-phase-3-atogepant-qulipta-data-for-preventive-treatment-chronic-migraine.htm?ref=fdaweb.com) Qulipta met its primary endpoint of statistically significant reduction from baseline in mean monthly migraine days compared to placebo across the 12-week treatment period. The drug also achieved statistically significant improvements in all secondary endpoints, it says.

Qulipta was approved by FDA on 9/2021 and is said by AbbView to be the only oral calcitonin gene-related peptide receptor antagonist in the country specifically developed for the preventive treatment of episodic migraine.