The U.S. Food and Drug Administration granted priority review status to the new drug application for Jazz Pharmaceuticals plc's Vyxeos liposome injection, an investigational drug for acute myeloid leukemia, a rapidly progressing and life-threatening blood cancer.
Jazz Pharmaceuticals' application contains clinical data from five studies, including a phase 3 trial which met its primary endpoint.
The drug was previously granted breakthrough therapy designation by the FDA in May 2016 to treat adult patients with therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes. It also received fast track designation from the FDA to treat elderly patients with secondary acute myeloid leukemia.
Vyxeos has also received orphan drug designation from the FDA and European Commission for the treatment of acute myeloid leukemia.