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# FDA Delays Decision on Agios’ Mitapivat sNDA for Thalassemia
- URL: https://www.fdaweb.com/fda-delays-decision-on-agios-mitapivat-snda-for-thalassemia/
- Published: 2025-12-08T12:00:00.000Z
- Updated: 2026-09-14T15:28:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160340

FDA has delayed its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both transfusion-dependent and non-transfusion-dependent forms of alpha- and beta-thalassemia. The agency had been expected issue a decision by 12/7, but it informed Agios that its review remains ongoing.

According to the company, FDA is working with Agios to finalize product labeling and a Risk Evaluation and Mitigation Strategy program. The agency has not asked for any new efficacy or safety data, and Agios says none has been submitted beyond what was included in the original filing. Additionally, a revised timeline for a decision was not provided by the agency.

Mitapivat, already approved in the U.S. for pyruvate kinase deficiency, is one of Agios’ key pipeline programs as the company expands its focus on rare hematologic diseases.