Posted by Michael Wonder on 04 Apr 2017
Jazz Pharmaceuticals completes rolling submission of new drug application for Vyxeos (CPX-351), an investigational treatment for acute myeloid leukaemia
3 April 2017 - Jazz Pharmaceuticals today announced the completion on 31 March 2017 of a rolling submission of a new drug application to the U.S. FDA for the approval of Vyxeos (cytarabine and daunorubicin) liposome for injection, an investigational treatment for acute myeloid leukaemia, a rapidly progressing and life-threatening blood cancer.
The company has requested a priority review for the Vyxeos application, which, if granted, would accelerate the expected timing of the FDA's review.
