Silver Spring, MD (Press Release) – On March 30, 2016, the U. S. Food and Drug Admin­istra­tion approved Defitelio (defibrotide sodium, Jazz Pharma­ceu­ticals, Inc.) for the treat­ment of adult and pediatric patients with hepatic veno-occlusive disease (VOD), also known as sinusoidal obstructive syn­drome, with renal or pul­monary dysfunction fol­low­ing hematopoietic stem-cell trans­plan­ta­tion (HSCT).

The efficacy of defibrotide sodium was in­ves­ti­gated in 528 patients treated on three studies: two prospective clin­i­cal trials and an expanded access study. The patients enrolled had a diag­nosis of hepatic VOD with multi-organ dysfunction after trans­plan­ta­tion. They received …