Gentium Receives Positive CHMP Opinion For Defitelio

(RTTNews) - Italian drugmaker Gentium S.p.A. (GENT) announced Friday that, following its request for re-examination, the European Medicines Agency's or "EMA" Committee for Medicinal Products for Human Use or CHMP adopted a positive opinion for Defitelio recommending a Marketing Authorization Application or MAA under exceptional circumstances, for the treatment of severe hepatic veno-occlusive disease or VOD in adults and children undergoing hematopoietic stem cell transplantation therapy.

The company said that the European Commission or "EC" will review the positive opinion from the CHMP, as they have the authority to grant marketing authorization. The EC generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union or EU countries. Upon approval, each member state will then determine the individual country price and the level of reimbursement.

In March, Gentium S.p.A. announced that it received negative opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP, on Defibrotide for the treatment and prevention of hepatic veno-occlusive disease or VOD, in adults and children undergoing blood stem cell transplantation therapy. The CHMP recommended the refusal of the marketing authorization for Defibrotide as it concluded that the benefits of the drug did not outweigh its risks.

The company had said that it planned to appeal the negative opinion issued by the CHMP as it remains convinced of the favorable benefit/risk profile of Defibrotide.