Jazz Pharmaceuticals plc has filed a Marketing Authorization Application (MAA) to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for Vyxeos 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. 
 
The MAA submitted for Vyxeos includes clinical data from five studies, including the pivotal Phase III study, which demonstrated a statistically significant improvement in overall survival for Vyxeos versus standard of care.
 
“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, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals. “We are passionate about bringing a new treatment option for high-risk AML to the appropriate patients in the EU as quickly as possible and look forward to working with the CHMP during this review process.”