European CHMP to discuss licensing application for defibrotide to treat and prevent hepatic veno-occlusive disease

Source: GlobeNewswire Area: News Gentium S.p.A has announced that its Marketing Authorisation Application (MAA) for defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy, will be on the agenda for discussion at the European Medicines Agency's Committee for Medicinal Products for Human Use meetings scheduled to be held on February 18-21, 2013.   Certain high-dose conditioning regimens used as part of stem cell transplantation can damage the lining cells of hepatic blood vessels and result in VOD, a blockage of the small veins in the liver that leads to liver failure and can result in significant dysfunction in other organs such as the kidneys and lungs.   At present there is no approved agent for the treatment or prevention of VOD in the US or EU.
Source: NeLM - News - Category: Drugs & Pharmacology Source Type: news