Jazz's Vyxeos under Priority Review for AML

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) said FDA accepted and granted Priority Review to its NDA for Vyxeos (CPX-351) to treat acute myelogenous leukemia (AML). Spokesperson Jacqueline Kirby told BioCentury its PDUFA date is Sept. 30.

Vyxeos is a liposomal formulation of cytarabine and daunorubicin encapsulated at a 5:1 molar ratio using CombiPlex technology. Jazz gained the candidate through its $1.5 billion acquisition of Celator Pharmaceuticals Inc., which closed in July 2016. Vyxeos has breakthrough therapy and Fast Track designations from FDA, as well as Orphan Drug designations from FDA and EMA, to treat AML (see BioCentury, June 6, 2016)...