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.
Source:
European Medicines Agency
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.