Jazz Pharmaceuticals Announces FDA Acceptance of NDA for VYXEOS

Jazz Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its recently submitted New Drug Application (NDA) for  VYXEOS™ (cytarabine and daunorubicin) liposome injection, an investigational treatment for acute myeloid leukemia (AML), a rapidly progressing and life-threatening blood cancer.

Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists.  The granting of Priority Review for the VYXEOS NDA accelerates the timing of the FDA review of the application compared to a standard review.

“We are pleased by the FDA’s acceptance of the NDA filing with Priority Review as this action emphasizes the need for new treatments for patients living with AML,” said Karen Smith, M.D., Ph.D., executive vice president, research and development and chief medical officer at Jazz Pharmaceuticals.  “We look forward to working with the FDA during this review process to obtain approval of VYXEOS as quickly as possible, as AML is the most common of all adult leukemias and AML patients have among the lowest survival rates.”

The NDA submission 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.

VYXEOS received Breakthrough Therapy Designation from the FDA in May 2016 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. VYXEOS was also granted Fast Track Designation for the treatment of elderly patients with secondary AML by the FDA, and Orphan Drug Designation by the FDA and the European Commission for the treatment of AML.

About VYXEOS (CPX-351)

VYXEOS (cytarabine and daunorubicin) liposome for injection, or CPX-351, is an investigational product being evaluated for the treatment of AML and is a combination of cytarabine and daunorubicin encapsulated within a nano-scale liposome at a 5:1 molar ratio.  The proposed trade name, VYXEOS™, is conditionally approved by the FDA and is subject to confirmation upon approval of the NDA.