Gentium S.p.A. Submit 2nd LoOIs Response to the European Medicines Agency's CHMP for Defibrotide MAA
12/18/2012 8:54:58 AM
VILLA GUARDIA, Italy, Dec. 18, 2012 (GLOBE NEWSWIRE) -- Gentium S.p.A. (Nasdaq:GENT) (the "Company") today announced that it has submitted responses to the second List of Outstanding Issues ("LoOIs") to 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. Gentium expects to receive an opinion from the CHMP regarding the approval of Defibrotide during the first quarter of 2013, based on the EMA review process timeline.