Gentium Receives European Commission's Marketing Authorization For Defitelio

(RTTNews) - Gentium S.p.A. (GENT) announced that the European Commission has granted a Marketing Authorization for Defitelio (defibrotide) for the treatment of severe hepatic veno-occlusive disease or VOD in adults and children undergoing hematopoietic stem cell transplantation therapy.

The company said it plans to begin commercialization of Defitelio in the European Union in December 2013.

"The decision allows Gentium to market Defitelio in the 28 Member States of the EU. We expect to begin commercial sales of Defitelio through our own sales force and through our distributor partners by the end of 2013," said Adrian Haigh, SVP Commercial Operations and Chief Operating Officer of Gentium GmbH.

Veno-occlusive disease or VOD is a potentially life-threatening condition, which typically occurs as a significant complication of stem cell transplantation. 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 (so-called severe VOD).

Stem cell transplantation is a frequently used treatment modality following high-dose chemotherapy and radiation therapy for hematologic cancers and other conditions in both adults and children.