imlifidase (Hansa Biopharma)

Imlifidase (marketed under the brand name Idefirix) is a recombinant cysteine protease derived from the immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes (IdeS). It specifically targets and cleaves all four subclasses of human IgG at the lower hinge region, generating one F(ab')2 fragment and one homodimeric Fc fragment. This cleavage effectively neutralizes IgG-mediated effector functions, including complement-dependent cytotoxicity (CDC) and antibody-dependent cell-mediated cytotoxicity (ADCC). Developed by Hansa Biopharma, imlifidase is conditionally approved in the European Union, United Kingdom, Switzerland, Australia, and Israel for the desensitization of highly sensitized adult kidney transplant recipients with a positive crossmatch against an available deceased donor. It is also under FDA review in the United States for the same indication. Additionally, imlifidase is being investigated in clinical trials for other IgG-mediated conditions, including antibody-mediated rejection (AMR), Guillain-Barré syndrome (GBS), ANCA-associated vasculitis, neuromyelitis optica spectrum disorder (NMOSD), and Crigler-Najjar syndrome, and has been evaluated as a pre-treatment to enable gene therapy in patients with pre-existing anti-AAV antibodies.

Brand names

Idefirix

Other names

IdeSIdeS recombinantIgG endopeptidaseimilfidaserecombinant IdeS