Hansa Biopharma is a leader in the development of immunomodulatory enzyme technology to treat rare IgG-mediated diseases. Recently, the company announced that the European Medicines Agency (EMA) Committee for Human Medical Products (CHMP) has issued a positive review opinion, recommending conditional approval of the new IgG antibody degrading enzyme Idefirix (imlifidase) for use with available death supplies Adult cross-matched positive, highly sensitive adult kidney transplant patients undergo desensitization treatment. Now, CHMP's comments will be submitted to the European Commission (EC) for review, which is expected to make a final review decision in the third quarter of this year.
imlifidase is a unique antibody-cleaving enzyme derived from Streptococcus pyogenes, which can specifically target IgG and inhibit IgG-mediated immune responses. Application imlifidase is a new method to eliminate pathogenic IgG, it has a rapid onset mode, can quickly cut IgG antibody and inhibit its reactivity within a few hours after administration.
Currently, imlifidase is being developed as a treatment for kidney transplantation in highly sensitive patients. This medicine is a new type of antibody degrading enzyme that can eliminate the immune barrier. Imlifidase is administered as a single intravenous infusion before transplantation and can quickly inactivate donor specific antibodies (DSAs). This drug has the potential to significantly increase the chance of kidney transplantation in highly sensitive patients.
Among the highly sensitive patients waiting for kidney transplantation, there is a major unmet medical need. These patients are often still in a weak disease state during long-term dialysis treatment, and the chance of receiving kidney transplantation is very limited. Clinical data shows that imlifidase can quickly and specifically cleave IgG antibodies, successfully enabling these patients to carry out life-saving kidney transplantation. The long-term follow-up data released in March this year showed that after highly sensitive patients received imlifidase treatment and kidney transplantation, the 2-year survival rate of the graft was as high as 89%.
S?ren Tulstrup, President and CEO of Hansa Biopharma, said: "We are very pleased to receive a positive opinion from CHMP. This gives hope to thousands of highly sensitive patients in Europe who are waiting for life-saving kidney transplants while giving the company An important step towards becoming a biopharmaceutical company at the commercial stage."
On February 28, 2019, based on data from four phase II studies completed in Sweden, France, and the United States, EMA accepted the marketing authorization application (MAA) for imlifidase in kidney transplantation. Each study reached all primary and secondary endpoints, proving the effectiveness and safety of imlifidase's successful kidney transplantation.
imlifidase is supported through EMA's Priority Medicines (PRIME) program, which provides early and enhanced scientific and regulatory support for drugs with unique potential to address significant unmet medical needs in patients. In May 2017, imlifidase was granted PRIME qualification by EMA
In the United States, after reaching an agreement with the FDA, Hansa Biopharma submitted a research protocol to the FDA on June 17, 2020. This randomized controlled clinical study is scheduled to begin in the fourth quarter of this year and recruits 45 highly sensitive patients in 10-15 centers. The data may support the submission of a biological product license application (BLA) in the United States before 2023.