Jazz Pharmaceuticals announced that the European Commission approved Vyxeos® 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine.
“Vyxeos is the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase 3 study of older adult patients with newly diagnosed therapy- related AML or AML with myelodysplasia-related changes,” said Daniel Swisher, president and chief operating officer at Jazz Pharmaceuticals. “Jazz is committed to making Vyxeos available to patients in the EU and we will now pursue rolling launches of Vyxeos across the European Union on a country-by-country basis as pricing and reimbursement decisions are made.”
The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.
Vyxeos 44 mg/100 mg powder for concentrate for solution for infusion is an advanced liposomal formulation that delivers a synergistic combination of daunorubicin and cytarabine to leukaemia cells for a prolonged period of time. Based on data in animals, Vyxeos liposomes accumulate and persist in high concentration in the bone marrow, where they are preferentially taken up intact by leukaemia cells. Vyxeos is the first product developed with the company’s proprietary CombiPlex® platform, which enables the design and rapid evaluation of various combinations of therapies. Vyxeos received Orphan Drug Designation (ODD) by the European Commission in January 2012 with retention of the ODD reaffirmed in July 2018 following assessment by the Committee for Orphan Medicinal Products (COMP) and by the U.S. Food and Drug Administration (FDA) in September 2008 for the treatment of AML. Vyxeos received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the United Kingdom. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion in June 2018 recommending marketing authorisation for Vyxeos. Vyxeos received U.S. FDA approval and orphan drug exclusivity in August 2017.
Headquartered in Dublin (Ireland), Jazz Pharmaceuticals is an international biopharmaceutical company that has a diverse portfolio of products and product candidates with a focus in the areas of sleep and hematology/oncology.