Idefitrix Lowers Sensitivity of Patients making them more Receptive for Kidney Transplant
Idefitrix a drug indicated for patients awaiting kidney transplant is being recommended by European Medicines agency for conditional marketing authorization.
Idefitrix is indicated for sensitized adult patients who are awaiting kidney transplant. Tests are performed to confirm whether a patient is an eligible recipient for a kidney transplant. The antibodies of a patient are a major determinant of receptivity and highly sensitized patients are very likely to reject this new kidney supplied from a donor therefore a need to desensitise making them eligible for transplant.
Streptococcus pyogenes is a bacterium that has supplied an enzyme capable of breaking down Immunoglobulin G (IgG) the antibody produced by a Highly sensitive transplant patient. This enzyme is include in Idefitrix and breaks down IgG reducing the sensitivity thus preventing the patient’s immune system from rejecting the transplant organ.
A recommendation for conditional approval has been made because Idefitrix fulfills an unmet medical need. This sought of approval is given when incomplete data of a drug (data that indicates the risk) does not outweigh the benefits of a medicine. Moving forward the company is required to submit additional efficacy and safety data based on one observational follow-up study and one post-approval efficacy study.
Six-month clinical trials, a three open label and single arm study was conducted to determine the efficacy and safety of Idefitrix as a pre-transplant medication to reduce donor specific IgG ensuring eligibility of highly sensitized kidney transplant candidates. The study elicited success in all 46 candidates who partook in the trials indicative of optimal kidney function and graft survival after six months.
Pneumonia, urinary tract infection (UTI), sepsis and infusion-related reactions were the most common adverse reactions reported with this treatment. The effect of the drug is temporary and does not preclude the need for standard immune suppression in kidney transplant patients. In line with this, conditional recommendation will be passed onto the European Commission for a decision.