Jazz Pharmaceuticals (JAZZ) Commences Vyxeos NDA Rolling Submission

October 3, 2016 8:33 AM EDT

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Jazz Pharmaceuticals plc (Nasdaq; JAZZ) announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) on September 30, 2016, seeking marketing approval of Vyxeos (cytarabine and daunorubicin liposome injection), an investigational agent for the treatment of acute myeloid leukemia (AML). The company expects to complete the submission of the NDA by early 2017, and will request a priority review.

"Our initiation of the rolling NDA submission for Vyxeos brings us closer to an important goal of providing a new treatment option for patients with acute myeloid leukemia, a devastating and life-threatening disease," said Karen Smith M.D., Ph.D., global head of research and development and chief medical officer at Jazz Pharmaceuticals. "AML represents a disease area within the hematological cancers, where there remains a significant unmet medical need. Vyxeos, if approved, would be the first new treatment demonstrating a significant advancement in treating AML in over 20 years."

Vyxeos was granted Breakthrough Therapy Designation in May 2016 for the treatment of adults with therapy-related AML or AML with myelodysplasia-related changes. The FDA grants Breakthrough Therapy designation to expedite the development and review of new medicines that are intended to treat serious or life-threatening diseases when the clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on at least one clinically significant endpoint. The Breakthrough Therapy designation allows a company to submit individual sections of its NDA for review by the FDA as they are completed rather than waiting until the entire application is complete before it can be submitted and reviewed.

Celator Pharmaceuticals, Inc. completed and announced the results of its Phase 3 trial evaluating Vyxeos in patients with high-risk AML in March 2016. Jazz Pharmaceuticals completed the acquisition of Celator Pharmaceuticals in July 2016.

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