Agios Gets February 1, 2027 PDUFA Goal Date for Mitapivat sNDA
The FDA requested additional information on whether a REMS is necessary. Agios says it is launch-ready and in labeling discussions with the agency.
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11:05:03 AM UTC
SquawkNews
Agios said the FDA extended the PDUFA goal date for mitapivat’s sickle cell disease sNDA to Feb. 1, 2027 after classifying Agios’ REMS-related submission as a major amendment. Labeling and potential REMS discussions are ongoing.Material DetailsContext by AI AnalystThis is a mid-cycle regulatory upd…