BRIEF—Jazz Pharma files for European approval of Vyxeos

Ireland incorporated Jazz Pharmaceuticals has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Vyxeos (daunorubicin and cytarabine) powder for concentrate for infusion to treat adults with high-risk acute myeloid leukemia (AML) defined as therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

The CHMP granted Vyxeos accelerated assessment, which is designed to reduce the review timeline for products of major interest for public health and therapeutic innovation.

Vyxeos also received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the UK.

A PIM designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with the potential to address an unmet medical need.

“If approved, Vyxeos will become the first new chemotherapy treatment option specifically for

European patients with therapy-related AML or AML with myelodysplasia-related changes,” said Karen Smith, executive vice president, R&D and chief medical officer at Jazz Pharmaceuticals.