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Rigel Ready To Hit The Ground Running After Early AML Drug Approval

Rezlidhia PDUFA Date Was Mid-February

 
• By Kevin Grogan

Rezlidhia, which was only recently licensed by Rigal from Novo Nordisk-owned Forma Therapeutics, should challenge the market dominance of Servier's Tibsovo in the IDH-1 inhibitor subset of acute myeloid leukemia patients. 

Leukemia
• Source: Shutterstock

Christmas has come early for Rigel Pharmaceuticals, Inc. with US regulators giving the green light to Rezlidhia a couple of months sooner than expected but the US firm is all set to make the acute myeloid leukemia (AML) drug available by the end of the year.

The US Food and Drug Administration has approved Rezlidhia (olutasidenib) for the treatment of relapsed or refractory AML in patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation

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