Conditional EC approval for Hansa's Idefirix
The European Commission has granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplants patients, says Lund, Sweden-based enzyme specialist Hansa Biopharma (STO: HNSA).
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 today's decision from the European Commission to approve Idefirix in highly sensitized kidney transplant patients. 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 and chief executive of Hansa Biopharma.
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