Gentium Receives EC Marketing Authorization for Defitelio
Gentium S.p.A. (NASDAQ: GENT) announced today that the European Commission has granted a Marketing Authorization for Defitelio® (defibrotide) for the treatment of severe hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy. Defitelio® is the first approved treatment in the European Union for this life-threatening condition. This authorization is the formal endorsement of the positive opinion received from the European Medicine Agency's ("EMA") Committee for Human Medicinal Product ("CHMP") on July 26, 2013. The Company intends to begin commercialization of Defitelio® in the European Union in December 2013.
"Today's authorization of Defitelio® represents an important milestone for Gentium," said Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "As the first drug to be approved for the treatment of severe VOD, Defitelio® will provide physicians with a life-saving option addressing a high unmet medical need for a disease with a high mortality rate, in excess of 80%. Gentium is proud of this achievement, which we believe will provide comfort and hope for patients and their families."
"The decision allows Gentium to market Defitelio® in the 28 Member States of the EU. We expect to