The EU Commission has granted conditional approval for use of Hansa Biopharma's Idefirix (imlifidase) to desensitise kidney transplant patients with a highly sensitised immune system.
The approval covers the drug's use for adult kidney transplant patients with a positive crossmatch against an available deceased donor.
Idefirix is an immunosuppressant that reduces the level of donor specific antibodies, thus enabling transplantation.
The drug was reviewed under the European Medicines Agency’s (EMA) PRIority MEdicines (PRIME) programme, which support medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.
“We are very excited about [the] decision from the European Commission to approve Idefirix in highly-sensitised kidney transplant patients. This is the first approved drug for Hansa Biopharma and will bring hope to the thousands of highly-sensitised patients across Europe waiting for a life-saving kidney transplant,” said Søren Tulstrup, president and chief executive of the Swedish firm.
A post-approval study will be initiated in parallel with EU launch following the market authorisation, Hansa noted.