Jazz begins Vyxeos NDA submission

Jazz Pharmaceuticals plc (NASDAQ:JAZZ) started submitting a rolling NDA to FDA for Vyxeos ( CPX-351) to treat acute myeloid leukemia (AML). The company expects to complete the submission in early 2017, and said it plans to request Priority Review.

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 (see BioCentury, June 6). ...