Agios Pharmaceuticals Submits Supplemental New Drug Application to FDA for Mitapivat
MT Newswires Live
May 12
Agios Pharmaceuticals (AGIO) said Tuesday it has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking accelerated approval of mitapivat for the treatment of sickle cell disease.
The submission is supported by data from the RISE UP Phase 2 and Phase 3 program of the oral pyruvate kinase activator in sickle cell disease and follows prior agreement with the FDA on a required confirmatory trial under the accelerated approval pathway.
The company expects to receive FDA filing acceptance confirmation and a review timeline in the third quarter of 2026, following the agency's 60-day review period, it added.
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