VILLA GUARDIA, Italy, Oct. 10, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that it has received a second List of Outstanding Issues ("LoOIs") from the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") in connection with the Company's Marketing Authorization Application ("MAA") for Defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing haematopoietic stem cell transplantation therapy.
The second LoOIs has reset the EMA's approval timetable back to Day 180. The Company plans to submit its response to the LoOIs within 60 days, in line with the new regulatory timetable. A recommendation on the approval of Defibrotide is now expected in early Q1 2013, based on the EMA review process timeline.
Dr. Khalid Islam, Chairman and CEO of the Company, commented, "In the interests of haematopoietic stem cell transplant patients, with or at high risk of developing VOD, Gentium remains committed to working with the rapporteurs and the CHMP to obtain approval of this potentially lifesaving therapy."About the EMA Review Process: More information can be obtained from the EMA website www.ema.europa.eu . About VOD Veno-occlusive disease (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. At present there is no approved agent for the treatment or prevention of VOD in the United States or the European Union.