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European Commission approves Vyxeos to treat certain types of high-risk acute myeloid leukaemia

The European Commission has approved Vyxeos 44 mg/100mg 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, manufacturer Jazz Pharmaceuticals has announced.

 

Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine, Jazz Pharmaceuticals said.

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The EC approval extends to all European member states as well as Iceland, Norway sand Liechtenstein.

 

Jazz Pharmaceuticals president and chief operating officer Daniel Swisher said: 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.Jazz is committed to making Vyxeos available to patients in the EUand 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.”

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