Jazz Pharmaceuticals Announces FDA Approval of Vyxeos™


Vyxeos™ (daunorubicin and cytarabine) represents the first new chemotherapy advance in more than 40 years for these adults with AML. It is a liposome formulation of a fixed combination of daunorubicin and cytarabine for intravenous infusion. Vyxeos is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC. The FDA granted the Vyxeos application Priority Review status, designated Vyxeos as a Breakthrough Therapy and also granted Fast Track Designation. Vyxeos received Orphan Drug Designation by the FDA and the European Commission for the treatment of AML.

The safety and efficacy of Vyxeos were studied in 309 patients with newly diagnosed t-AML or AML-MRC who were randomized to receive Vyxeos or separately administered treatments of daunorubicin and cytarabine. The trial measured how long patients lived from the date they started the trial (overall survival). Patients who received Vyxeos lived longer than patients who received separate treatments of cytarabine and daunorubicin (median overall survival 9.56 months versus 5.95 months).

Designed with Jazz's CombiPlex® proprietary technology, Vyxeos is a unique combination of daunorubicin and cytarabine encapsulated within a nano-scaled liposome at a 5:1 molar ratio. This system delivers the two APIs to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models. Vyxeos is the first product developed with the company's proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies. The CombiPlex Technology offers a unique combination of two proprietary nano-scale delivery platforms. First, phospholipid-based liposomes that control the release and distribution of water-soluble drugs and amphipathic drugs as well as nanoparticles to control the release and distribution of non-water-soluble (hydrophobic) drugs. Vyxeos is a great example for a continuous and improving development of liposomal technology.

FDA Press Announcement, August 4th, 2017