EC approves Otsuka and Astex' AML drug

19 September 2023

The European Commission (EC) has approved Otsuka Pharmaceutical (TYO: 4578) and its subsidiary Astex Pharmaceuticals’ Inaqovi (oral decitabine and cedazuridine) as monotherapy for the treatment of adults with newly-diagnosed acute myeloid leukemia (AML) who are ineligible for standard induction chemotherapy

This decision applies to the European Economic Area (EEA) and makes Inaqovi the first and only oral hypomethylating agent licensed in the region in this patient population.

The approval is based on results from the Phase III ASCERTAIN trial investigating the pharmacokinetic exposure equivalence of the novel oral fixed-dose combination versus intravenous (IV) decitabine in AML patients.

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