CHMP recommends Defitelio (Gentium) for Veno Occlusive Disease
On 25 July 2013, the CHMP, following a re-examination procedure, adopted a final positive opinion, recommending to grant a marketing authorisation for the medicinal product Defitelio from Gentium, 80 mg/mL concentrate for solution for infusion intended for the treatment of severe hepatic Veno-Occlusive Disease (VOD) also known as Sinusoidal Obstructive Syndrome (SOS) in haematopoietic stem-cell transplantation (HSCT) therapy.
Defitelio was designated as an orphan medicinal product on 29 July 2004. The active substance of Defitelio is defibrotide, a drug for the treatment of severe veno-occlusive disease (VOD) in patients undergoing haematopoietic (blood) stem-cell (B01AX01). The mechanism of action of defibrotide has not been fully elucidated.
Defibrotide was rejected by the FDA in March 2013.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins