Kidney transplant new drug! The new IgG antibody cutting enzyme Idefirix has been approved by the European Union for use in highly sensitive kidney transplant patients!

August 27, 2020 // -- Hansa Biopharma is a leader in the development of immunomodulation enzyme technology to treat rare IgG-mediated diseases.
, the company announced that the European Commission (EC) has conditions to approve the new IgG antibody degradation enzyme Idefirix (imlifidase) for highly sensitive kidney transplant patients.
the EC's formal approval comes two months after the European Medicines Agency's (EMA) Commission on Human Pharmaceutical Products (CHMP) issued an active review.
, CHMP has recommended conditional approval of Idefirix for desensitization treatment in adult patients with cross-matching positive, highly sensitive kidney transplants with available death providers.
Idefirix's active pharmaceutical ingredient is imlifidase, a unique antibody cutting enzyme derived from Streptococcus pyogenes, which specificly targets IgG and suppresses Img-mediated immune responses.
application imlifidase is a new way to eliminate pathogenic IgG, which has a fast-acting mode that quickly cuts IgG antibodies and inhibits their reactivity within hours of being given.
, imlifidase is being developed as a treatment for kidney transplants in highly sensitive patients.
the drug is a new type of antibody degradation enzyme that eliminates the immune barrier.
imlifidase, as a single intravenous infusion before transplantation, can quickly inactivate donor specific antibodies (DSAs), which has the potential to significantly improve the chances of kidney transplantation for highly sensitive patients.
there is a significant unsophedited medical need among highly sensitive patients awaiting kidney transplantation, who are often still in a weak state of disease during long-term dialysis treatment and have limited access to kidney transplants.
clinical data show that imlifidase can quickly and specificly cut IgG antibodies, successfully enabling these patients to carry out life-saving kidney transplants.
follow-up data released in March this year showed that the two-year survival rate of transplants was as high as 89% after highly sensitive patients received imlifidase treatment and kidney transplants.
Soren Tulstrup, President and CEO of Hansa Biopharma, said, "We are very excited about the EC's decision today to approve Idefirix for the treatment of highly sensitive kidney transplant patients.
is the first drug approved by Hansa and will offer hope to thousands of highly sensitive patients in Europe waiting for life-saving kidney transplants.
" Idefirix has been reviewed as part of the EMA's Priority Medicines (PRIME) program.
program provides early and enhanced scientific and regulatory support for drugs with unique potential to address significantly unseeded medical needs in patients.
may 2017, imlifidase was granted PRIME status by the EMA.
February 28, 2019, based on data from four Phase II studies completed in Sweden, France and the United States, the EMA accepted applications for a listing permit (MAA) for imlifidase in kidney transplants.
each study reached all major and secondary endpoints, demonstrating the effectiveness and safety of imlifidase in achieving kidney transplantation.
, Hansa Biopharma submitted a study to the FDA on June 17, 2020, following an agreement with the FDA.
the randomized controlled clinical study, which began in the fourth quarter of this year, recruited 45 highly sensitive patients in 10-15 centers in the United States, and the data may support the submission of biological product licensing applications (BLA) in the United States by 2023.
() Original origin: The EU Commission grants approval for IdefirixTM (imlifidase) in highly sensitized kidney patients in the European Union.