European approval for Vyxeos for certain high-risk AML patients

The European Commission approved Vyxeos (daunorubicin and cytarabine, liposomal formulation)44mg/100mg powder for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Shares of Ireland-incorporated Jazz Pharmaceuticals (Nasdaq: JAZZ), which gained US approval for Vyxeos in August 2017, edged up 1% to $169.09 on the news yesterday. At the time of the US approval, RBC Capital Markets’ analysts forecast peak sales of $235 million in 2022.

Vyxeos is the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase III 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 Vyxeosacross the European Union on a country-by-country basis as pricing and reimbursement decisions are made."