Main > A1. CORP. INDEX. An-Az > Astex Pharmaceuticals Inc./P C2 > 2023. 09.19. Onco.>AML>EU CE Mark
LONDON, UK, and PLEASANTON, CA, USA, 19th September 2023 – Otsuka Pharmaceutical Europe Ltd. (Otsuka) and Astex Pharmaceuticals, Inc. (Astex) today announce that the European Commission (EC) has approved INAQOVI® (oral decitabine and cedazuridine) as monotherapy for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy. The EC decision applies to the European Economic Area (EEA), which includes the EU member states, Iceland, Liechtenstein and Norway. INAQOVI® is the first and only oral hypomethylating agent licensed in the EEA in this patient population.
About decitabine and cedazuridine fixed-dose combination (INAQOVI®)
INAQOVI® is an orally administered, fixed-dose combination of the approved hypomethylating agent (HMA), decitabine (35 mg), together with cedazuridine (100 mg), an inhibitor of cytidine deaminase4-6. By inhibiting cytidine deaminase in the gut and liver, the fixed-dose combination is designed to allow for oral daily administration of decitabine over 5 days in a given cycle to achieve comparable systemic exposure to IV decitabine administered with the same dosing regimen7.
https://astx.com/otsuka-and-astex-announce-that-the-european-commission-has-approved-inaqovi-oral-decitabine-and-cedazuridine-for-the-treatment-of-adults-with-newly-diagnosed-acute-myeloid-leukaemia/
2023. 09.19. Onco.>AML>EU CE Mark's products
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