Gentium unlikely to get CHMP recommendation for defibrotide use in Hepatic Veno-Occlusive disease
Gentium S.p.A. had presented an oral explanation at the EMA Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application for Defibrotide to treat and prevent Hepatic Veno-Occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation,based on preliminary feedback from the CHMP,the Company expects an opinion recommending against approval of the Marketing Authorization Application for Defibrotide to treat and prevent Hepatic Veno-Occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
1 mins