Jazz Pharma stops enrollment in Phase III Defitelio trial
A Phase III study of Defitelio (defibrotide) for the prevention of hepatic veno-occlusive disease (VOD) has stopped enrollment, on the basis of a futility analysis.
The study was conducted as part of a post-marketing requirement related to safety. Multiple periodic safety analyses were conducted during the study and no new safety concerns were reported.
Jazz Pharmaceuticals (Nasdaq: JAZZ) picked up the compound through its $1 billion acquisition of Italian orphan drug developer Gentium in 2013. The firm subsequently extended rights to the drug to include the USA, through a deal with Sigma-Tau.
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