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Hansa Biopharma’s Idefirix granted conditional approval in EU


Hansa Biopharma has 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.

“This is the first approved drug for Hansa Biopharma and will bring hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant,” says Søren Tulstrup, President & CEO of Hansa Biopharma.

Part of the PRIME program

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 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.

Photo of Søren Tulstrup: Hansa Biopharma