US FDA approves Jazz Phama's Defitelio for hepatic veno-occlusive disease

Ireland-based biopharma firm Jazz Pharmaceuticals (Nasdaq: JAZZ) has gained US Food and Drug Administration approval for Defitelio (defibrotide).

The company has welcomed this as good news for patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstruction syndrome (SOS), with renal or pulmonary dysfunction following Hematopoietic Stem-Cell Transplantation (HSCT).

Bruce Cozadd, chairman and chief executive of Jazz Pharmaceuticals, said: “FDA's approval of Defitelio underscores the importance of Defitelio to children and adults as the first and only proven treatment for this rare and often deadly complication of stem-cell transplantation. Defitelio is a clinically significant therapeutic advance because it is a potentially curative intervention for patients with VOD, which may save lives with a single course of therapy. Before today, patients in the US had no approved options.”