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
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