Gentium S.p.A. Provides Update on the Review of Defibrotide Marketing Authorization Application
9/26/2012 9:19:19 AM
VILLA GUARDIA, Italy, Sept. 26, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that, following the Company's presentation of Oral Explanations to the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") on September 19, 2012, the CHMP has decided to adopt a second List of Outstanding Issues ("LoOI") relating to 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. Defibrotide was designated as an orphan drug product in the European Union on July 29, 2004 for the treatment and prevention of VOD.