Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Shots: The US FDA has accepted the sNDA & granted priority review to mitapivat, under FDA’s accelerated approval pathway, for the treatment of Sickle Cell Disease (PDUFA: Nov 1, 2026) sNDA was supported by the global P-II/III (RISE UP) trial assessing mitapivat (100mg, PO, BID; n=138) vs PBO (n=69) in 207 pts with SCD (≥16yrs.) for 52wks., followed by an OLE period, during which all pts receive mitapivat Mitapivat is being assessed in the confirmatory P-III (REIGNITE) trial assessing its clinical benefit against PBO on reducing transfusion burden in pts (≥12yrs.; n=~159) with SCD Ref: Globenewswire  |  Image: Agios | Press Release Related News: Agios Pharmaceuticals Licenses Cevidoplenib from Oscotec in a ~$165M Deal PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with us at connect@pharmashots.com The post Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease appeared first on PharmaShots.