Gentium Announces Submission of a Marketing Authorization Application for Defibrotide to the European Medicines Agency (GENT)

Gentium S.p.A. GENT today announced it has submitted a Marketing Authorization Application, under the centralized licensing procedure, to the European Medicines Agency for Defibrotide for the treatment and prevention of hepatic veno-occlusive disease in haematopoietic stem-cell transplantation therapy, in adults and children. "Hepatic VOD is a serious complication of stem-cell transplantation that can be associated with a high morbidity and mortality," stated Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A. "Defibrotide has now been used in more than 240 clinics across 33 countries as a result of a large compassionate use program and the on-going named patient programs. If EMA approval is obtained, Defibrotide would become the first drug to be approved for VOD in either the treatment or prevention setting."