CHMP recommends Inaqovi for the treatment of acute myeloid leukaemia.- Taiho/Otsuka.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inaqovi, intended for the treatment of acute myeloid leukaemia (AML). The applicant for this medicinal product is Otsuka Pharmaceutical Netherlands BV.
Inaqovi will be available as a 35 mg / 100 mg film-coated tablet containing a fixed combination of the active substances decitabine and cedazuridine (ATC code: L01BC58). Decitabine is a nucleoside metabolic inhibitor that inhibits the action of DNA methyltransferases, leading to hypomethylation of DNA and subsequent cellular differentiation and/or apoptosis. Cedazuridine is a cytidine deaminase inhibitor that increases systemic exposure to decitabine.
The benefit of Inaqovi in the treatment of AML is a comparable exposure equivalent to intravenous infusion of decitabine at 20 mg/m2, allowing for a similar efficacy as seen for IV decitabine, with a complete response rate of 21% with a median duration of response of 5.8 months and an overall response rate of 32%. The most common side effects is thrombocytopaenia. The most common serious side effects are febrile neutropenia and pneumonia.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.