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The FDA Has Not Yet Issued Regulatory Decision On Agios Pharmaceuticals' Supplemental New Drug Application For Mitapivat For Adult Patients With Non-transfusion-dependent And Transfusion-dependent Alpha- Or Beta-thalassemia, And It Remains Under Review.

Benzinga·12/08/2025 12:10:47
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  • The Prescription Drug User Fee Act (PDUFA) goal date issued by the FDA was December 7, 2025.
  • Agios is collaborating closely with the FDA to finalize the labeling documents and Risk Evaluation and Mitigation Strategy (REMS) materials. The FDA has not requested, and the company has not submitted, any new or additional efficacy or safety data.
  • The FDA has not provided a timeline for its regulatory decision. Agios continues to work expeditiously with the FDA to conclude the review of the sNDA.