CHMP changes its mind on Gentium's defibrotide
This article was originally published in Scrip
Executive Summary
The CHMP has reversed its decision not to recommend approval for Gentium's Defitelio (defibrotide 80mg/mL concentrate for solution for infusion) for hepatic veno-occlusive disease (VOD) also known as sinusoidal obstructive syndrome in hematopoietic stem-cell transplantation (HSCT) therapy.