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.
"We are very excited about this decision from the European Commision to approve Idefirix in highly sensitized kidney transplant patients. This is the first approved drug for HansaBiopharma and will bring hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant" says SørenTulstrup, president & CEO of Hansa Biopharma.
"This approval further serves as a validation of the potential of Hansa Biopharma's proprietary drug development engine and will transform the company into a commercial stage biopharmaceutical company that brings lifesaving and life altering therapies to patients with rare diseases who need them and generate value to society at large."
Idefirix has been reviewed as part of the European Medicines Agency's (EMA) PRIority MEdicines (PRIME) programs, which support medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
The first treatment with Idefirix is expected to be available to patients in select European countries during the fourth quarter 2020, as communicated earlier. A post-approval study will be initiated in parallel with the launch following the market authorization.