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# FDA Approves AbbVie’s Qulipta for Migraine Prevention
- URL: https://www.fdaweb.com/fda-approves-abbvies-qulipta-for-migraine-prevention/
- Published: 2021-09-30T12:00:00.000Z
- Updated: 2026-09-14T17:16:51.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150268

FDA has approved AbbVie’s Qulipta (atogepant) for the preventive treatment of episodic migraine in adults. The company [says](https://www.marketwatch.com/press-release/fda-approves-quliptatm-atogepant-the-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-the-preventive-treatment-of-migraine-2021-09-28?tesla=y&ref=fdaweb.com) Qulipta is the only oral calcitonin gene-related peptide receptor antagonist specifically developed for this indication.

AbbVie says the approval was supported by data from a clinical program evaluating the drug’s efficacy, safety, and tolerability in nearly 2,000 patients who experienced four to 14 migraine days per month, including a pivotal Phase 2b/3 study, a pivotal Phase 3 ADVANCE study, and a Phase 3 long-term safety study.