Saturday, June 30, 2018
Jazz Pharmaceuticals plc today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation of 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 fixed-ratio (1:5) of daunorubicin and cytarabine.
"Jazz is committed to bringing new and clinically meaningful treatment options to patients on a global basis, and we now look forward to bringing Vyxeos to adults with AML in the European Union," said Allen Yang, M.D., Ph.D., vice president, hematology/oncology therapeutic area head, and acting chief medical officer at Jazz Pharmaceuticals. "If approved by the European Commission, Vyxeos will become the first chemotherapy treatment option specifically for European patients with therapy-related AML or AML with myelodysplasia-related changes."
The Marketing Authorisation Application (MAA) for Vyxeos includes clinical data from five studies, including the pivotal Phase 3 study. Data from the Phase 3 study, which met its primary endpoint, were presented at the American Society of Clinical Oncology Annual Meeting in June 2016.
Jazz Pharmaceuticals filed a MAA for Vyxeos in November 2017 after the CHMP granted accelerated assessment, which is designed to reduce the review timeline for products of major interest for public health and therapeutic innovation. The positive opinion from the CHMP will be reviewed by the European Commission, which has the authority to approve medicines in all European Union Member States, Iceland, Norway and Liechtenstein.