EMA recommends granting a Marketing Authorisation for Decitabine / Cedazuridine (Inaqovi) oral therapy for newly diagnosed AML patients who are ineligible for standard induction chemotherapy
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On 20 July 2023, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product decitabine / cedazuridine (Inaqovi), intended for the treatment of acute myeloid leukaemia (AML). The EC Decision is expected by 3-4Q/2023.
The applicant for this medicinal product is Otsuka Pharmaceutical Netherlands B.V.
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 i.v. 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 neutropaenia and pneumonia.
The full indication is:
- Inaqovi is indicated as monotherapy for the treatment of adult patients with newly diagnosed AML who are ineligible for standard induction chemotherapy.
- Inaqovi should be prescribed by physicians experienced in the use of anticancer therapies.