New kidney transplant medicine! The new IgG antibody cutting enzyme Idefirix is about to be approved in the European Union for highly sensitive kidney transplant patients!

, June 25, 2020 /PRNewswire
/ -- Hansa Biopharma is a leader in the development of immunomodulating enzyme technology for the treatment of rare IgG-mediated diseasesRecently, the company announced that the European Medicines Agency (EMA) Human Pharmaceutical Products Committee (CHMP) has issued an active review, recommending conditional approval of the new IgG antibody degradation enzyme Idefirix (imlifidiase) for cross-matching with available dead donors positive, highly sensitive adult kidney transplant patients for desensitization treatmentThe chMP's comments will now be referred to the European Commission, which is expected to make a final review decision in the third quarter of this yearimlifidiase is a unique antibody cutting enzyme derived from streptococcus pyogenes, which specifically targets IgG and inhibits igG-mediated immune responseThe application of imlifidiase is a new method for eliminating pathogenic IgG, which has a fast-acting mode that rapidly cuts IgG antibodies and inhibits their reactivity within hours of administration, imlifidase is being developed as a treatment for kidney transplants in highly sensitive patientsThe drug is a new antibody degradation enzyme that eliminates the immune barrierImlifidase is administered as a single intravenous infusion prior to transplant, which rapidly inactivates donor-specific antibodies (donor-specific antibodies, DSAs), which has the potential to significantly improve the chances of kidney transplantation in highly sensitive patientsthere is a significant unmet medical need among highly sensitive patients waiting for kidney transplants, who are often in a state of weakness during long-term dialysis treatment, and their limited chances of receiving kidney transplantsClinical data show that imlifidase can quickly and specifically cut IgG antibodies, successfully enabling these patients to carry out life-saving kidney transplantsLong-term follow-up data released in March showed a two-year survival rate of 89 per cent for highly sensitive patients after receiving imlifidase treatment and kidney transplants"We are pleased to receive positive comments from CHMP," said S?ren Tulstrup, President and CEO ofHansa BiopharmaThis offers hope to the thousands of highly sensitive patients across Europe who are waiting for life-saving kidney transplants, and a major step towards becoming a commercial biopharmaceutical company"
28 February 2019, the EMA accepted the application for a listing permit (MAA) for a kidney transplant based on data from four phase II studies completed in Sweden, France and the United States Each study reached all primary and secondary endpoints, demonstrating the effectiveness and safety of imlifidase's successful kidney transplantation is supported through the EMA Priority Drugs (PRIME) program, which provides early and enhanced scientific and regulatory support for drugs with unique potential to address significantly unmet medical needs in patients In May 2017, imlifidase was granted PRIME eligibility by the EMA
and after agreeing with the FDA, Hansa Biopharma submitted a study to the FDA on June 17, 2020 The randomized controlled clinical study, which began in the fourth quarter of this year and recruited 45 highly sensitive patients in 10-15 centers, may support the filing of bioproduct licensing applications (BLA) in the United States by 2023 (BioValleyBioon.com) original source: Hansa Biopharmas positive CHMP opinion for Idefirix (imlifidase) for kidney sieu in EU .