BioCentury
ARTICLE | Clinical News

Defibrotide regulatory update

May 14, 2012 7:00 AM UTC

Gentium said it received Day 180 questions from EMA's CHMP related to the review of an MAA for defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy. The company, which did not disclose the questions, expects to submit responses within 60 days and expects a recommendation on the approval of defibrotide as early as next quarter. The product has Orphan Drug designation in the EU and U.S. to treat and prevent VOD and Fast Track designation in the U.S. to treat VOD.

Earlier this month, Gentium granted the PharmaSwiss S.A. division of Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX, Montreal, Quebec) exclusive rights to distribute defibrotide in Albania, Bosnia, Bulgaria, Croatia, Cyprus, Czech Republic, Greece, Hungary, Macedonia, Montenegro, Poland, Romania, Serbia, Slovenia and Slovakia (see BioCentury, May 7). ...