European CHMP recommends approval of imlifidase (Idefirix)

The license is for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor.

SPS commentary:

Imlifidase is a cysteine protease derived from the immunoglobulin G (IgG) ‑degrading enzyme of Streptococcus pyogenes. It cleaves the heavy chains of all human IgG subclasses (but no other immunoglobulins), eliminating Fc-dependent effector functions, including CDC and antibody-dependent cell-mediated cytotoxicity (ADCC). Thus, imlifidase reduces the level of donor specific antibodies, enabling transplantation.

A related press release highlights the use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.


European Medicines Agency

Resource links:

Press release