Jazz Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for filing with Priority Review the New Drug Application (NDA) for defibrotide for the treatment of patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with evidence of multi-organ dysfunction (MOD) following hematopoietic stem-cell transplantation (HSCT).
The NDA submission is based on safety and efficacy data from three clinical studies, as well as, a retrospective review of registry data from the Center for International Blood and Marrow Transplant Research. FDA review is expected to be completed by March 31, 2016.
The FDA granted defibrotide Orphan Drug designation in May 2003 and Fast Track designation. Defibrotide is being made available as an investigational new drug (IND) free of charge through an expanded access Treatment Protocol for the treatment of patients with hepatic VOD with evidence of MOD following HSCT.
For more information call (650) 496-3777 or visit JazzPharmaceuticals.com.