Drug news

CHMP rejects Defitelio (Gentium/SOBI)for Hepatic Veno- Occlusive disease

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Last updated:22nd Mar 2013

Published:22nd Mar 2013

Source: Pharmawand

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Defitelio (defibrotide) from Gentium/Swedish Orphan Biovitrium)intended for the treatment and prevention of Hepatic Veno-Occlusive disease in blood stem cell transplantation therapy. The drug was withdrawn from the FDA in August 2011.

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