EMA Recommends a Conditional Marketing Authorization for Kidney Transplant Medicine

The European Medicines Agency (EMA) has issued a statement, on June 26, 2020, recommending a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.

According to the recommendation, Idefirix should be used complementary to existing allocation programs for patients that have a very low chance of finding a matching kidney. Highly sensitized patients have elevated antibody levels making it more common for transplant rejection and therefore, the patients are deemed as ineligible for transplant. 

Idefirix is made of an enzyme that breaks down the antibodies produced by the patient. Through this mechanism, it is expected that the therapy will prevent the patient’s immune system from attacking the transplanted organ and ultimately reduce the risk of rejection.

The treatment has been supported through EMA’s Priority Medicines (PRIME) scheme, which supports medicines with the potential to address unmet medical needs. The conditional recommendation will be passed onto the European Commission for a decision on the adoption of marketing authorization throughout the European Union.

Source: EMA