India, Oct. 30 -- Agios Pharmaceuticals (AGIO) announced that the U.S. Food and Drug Administration (FDA) extended the review period for its supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease, setting a new PDUFA goal date of February 1, 2027.
The application was submitted under the FDA's accelerated approval pathway and granted Priority Review, with an original PDUFA goal date of November 1, 2026.
On October 9, 2026, the FDA requested additional information to evaluate whether a Risk Evaluation and Mitigation Strategy (REMS) is necessary for mitapivat in sickle cell disease.
Agios submitted its response on October 19, including approximately nine months of updated safety data through October 9, 2026, from the ...