The European Medicines Agency has accepted the company’s application for review of the marketing authorisation of imlifidase in kidney transplant
Swedish biopharmaceutical company Hansa Biopharma has received the positive opinion from the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) for Idefirix (imlifidase) to desensitise adult patients in kidney transplant.
The positive CHMP opinion recommends the conditional approval of Idefirix for the desensitisation treatment of highly sensitised adult kidney transplant patients with a positive crossmatch against an available deceased donor.
Hansa Biopharma president and CEO Søren Tulstrup said: “We are very excited to receive a positive opinion from the CHMP.
“This brings hope to the thousands of highly sensitized patients across Europe waiting for a life-saving kidney transplant and takes Hansa Biopharma one important step closer to becoming a commercial-stage biopharmaceutical company.
“Today’s decision by the CHMP further serves to validate the potential of Hansa Biopharma’s proprietary drug development engine to develop approvable immunomodulatory drug candidates for rare and serious diseases and comes at a time when we are significantly expanding our activities into autoimmune diseases, gene therapy and oncology.”
Idefirix is an antibody-cleaving enzyme derived from Streptococcus pyogenes
Idefirix is an advanced antibody-cleaving enzyme derived from Streptococcus pyogenes that particularly target IgG and inhibits IgG-mediated immune response.
The European Medicines Agency has accepted the company’s application for review of marketing authorisation of Idefirix in kidney transplant on 28 February 2019. EMA’s decision for review is based on data from four phase 2 studies conducted across Sweden, France and the US.
Idefirix has reached all the primary and secondary endpoints in the clinical studies and was supported through EMA’s PRIority MEdicines (PRIME) scheme.
Hansa Biopharma has submitted a study protocol to the FDA, following the overall agreement with the regulator, and is planning to conduct a randomised, controlled clinical study in the fourth quarter of 2020.
The company intends to recruit 45 highly sensitised patients at 10 to 15 centres in the US for the proposed clinical study, which is expected to support the company’s future BLA submission with the US FDA by 2023.