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# FDA to Review Agios Pyrukynd sNDA
- URL: https://www.fdaweb.com/fda-to-review-agios-pyrukynd-snda/
- Published: 2025-01-09T12:00:00.000Z
- Updated: 2026-09-14T14:50:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158457

FDA has accepted for review an Agios Pharmaceuticals sNDA for Pyrukynd (mitapivat) to treat adults with non-transfusion-dependent alpha- or beta-thalassemia. The agency set a PDUFA review goal date of 9/7.

A company [statement](https://investor.agios.com/news-releases/news-release-details/fda-accepts-agios-supplemental-new-drug-application-pyrukyndr?ref=fdaweb.com) says the sNDA is based on results from the ENERGIZE and ENERGIZE-T Phase 3 trials evaluating mitapavit versus placebo in adults with non-transfusion-dependent alpha- or beta-thalassemia, respectively.

Pyrukynd is described as a pyruvate kinase activator that is indicated to treat hemolytic anemia in adults with pyruvate kinase deficiency.