Gentium expands access to defibrotide under compassionate use basis
Gentium S.p.A has announced that it is expanding access to its investigational drug defibrotide for patients to treat severe veno-occlusive disease (VOD). The Villa Guardia, Italy, firm is taking this step because it has received "large numbers of requests" for the drug on a compassionate use basis. Gentium added that the expanded access will not affect the Phase III trial of the drug, since only patients who are not eligible to, or cannot, participate in the study can take advantage of the expanded access program. Defibrotide is an orphan drug that has been granted fast-track designation to treat severe VOD in stem cell transplant patients.