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news.Italian drug development firm Gentium has filed a new drug application (NDA) for Defibrotide with the US Food and Drug Administration (FDA) to treat adults and children with hepatic veno-occlusive disease (VOD), who are undergoing hematopoietic stem-cell transplantation (HSCT).
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The NDA submission was done on the basis of positive results from different trials which demonstrated that Defibrotide does not appear to increase the risk of complications in HSCT patients.
In the trials, which involved around 1,300 patients, the drug was well tolerated.
The company has already received FDA fast track status for Defibrotide for the treatment of severe VOD in recipients of stem cell transplants.
Gentium chairman and CEO Khalid Islam said Defibrotide has been used as an investigational drug in more than 250 clinics across 33 countries in the on-going global named-patient programs, and the US expanded access study.
"We are committed to working with the FDA on the approval of Defibrotide and with our partner, Sigma-Tau Pharmaceuticals on the future commercialization of Defibrotide," Islam said.