EU Commission grants conditional approval for Idefirix in highly sensitized kidney transplant patients in the European Union.- Hansa Biopharma

Hansa Biopharma , the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the European Commission has granted conditional approval for Idefirix in highly sensitized kidney transplants patients. The formal approval by the European Commission was received two months after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending conditional approval of Idefirix for the desensitization treatment of highly sensitized adult kidney transplant patients with a positive crossmatch against an available deceased donor. The first treatments with Idefirix is expected to be available to patients in select European countries during the fourth quarter 2020. A post-approval study will be initiated in parallel with the launch following the market authorization.