EC approves Otsuka and Astex’s Inaqovi for acute myeloid leukaemia

19 Sep 2023
www.pmlive.com
Drug ApprovalClinical ResultClinical Study
The European Commission (EC) has approved Otsuka Pharmaceutical and Astex Pharmaceuticals’s Inaqovi (oral decitabine and cedazuridine) as a monotherapy in certain acute myeloid leukaemia (AML) patients.
The EC’s decision, which specifically applOtsuka Pharmaceuticalwly dAstex PharmaceuticalsineInaqovi for stdecitabineuctiocedazuridinepy, makes Inaqovi the first oracute myeloid leukaemia (AML)oved in the European Economic Area for this patient population.
AML is a rapidly progressing cancer of the blood and bone marrow and the mostAMLmmon form of acute leukaemia in adults. Within Europe, the inciInaqovif AML is increasing, rising from 3.48 per 100,000 population in 1976 to 5.06 in 2013.
AMLrent treatment options forcancers with AML range from hospital-administered intravenous (Iacute leukaemia infusions or, for those who are unable to rAMLive chemotherapy, regimens based on parenterally administered hypomethylating agents.
By inhibiting cytidine deaminase in the guAMLnd liver, Otsuka and Astex’s decitabine and cedazuridine fixed-dose combination is designed to allow for oral daily administration of decitabine over five days in a given cycle to achieve comparable systemic exposure to IV decitabine administered with the same dosing regimen.
The EC’s approcytidine deaminasey results from the late-stage ASCEAstex trdecitabineich tcedazuridinee combination demonstrated pharmacokinetic exposure equivalence to a standard decitabineegimen of IV decitabine.decitabine
In addition to the EC approval, the European Medicines Agency previously agreed to a paediatric investigation plan for the oral combination treatment, which the partners say represents “an important mildecitabine the prospect of furthering clinical studies in children with AML”.
A paediatric investigation plan is aEuropean Medicines Agencyt ensuring that the necessary data is obtained through studies of children to support the authorisation of a medicine for this demographic in Europe.AML
The EC approval comes just over a month after Astex and MSD – known as Merck & Co in the US and Canada – expanded their drug discovery collaboration with the goal of identifying small-molecule candidates with activity towards a tumour suppressor protein.
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