Jazz Pharma initiates rolling submission to FDA for defibrotide for hepatic Veno-Occlusive Disease

Jazz Pharmaceuticals plc announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States FDA for defibrotide for the treatment of severe hepatic Veno-Occlusive Disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy. Defibrotide has been granted Fast Track Designation to treat severe VOD by the FDA.

Jazz Pharmaceuticals has acquired the rights to defibrotide in the U.S. and other markets in North America, South America and Central America. Jazz Pharmaceuticals markets defibrotide in Europe under the name Defitelio (defibrotide). Defitelio is the first and only licensed product in Europe for the treatment of severe hepatic VOD in patients over one month of age undergoing HSCT therapy.