Hansa Biopharma Announces Reimbursement in Italy for Idefirix as Desensitization Treatment for Highly Sensitized Patients in Kidney Transplantation
Hansa Biopharma, a pioneer in enzyme technology for rare immunological conditions, has announced that the Italian Medicine Agency (AIFA) has granted full access and reimbursement for the use of Idefirix®, the company’s first-in-class treatment, for the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor in Italy. The positive reimbursement decision is aligned with the conditional approval granted by EMA in August 2020.
Approximately 2,000 kidney transplantations are performed each year in Italy, with the majority (86%) from deceased donors. Of more than 6,000 patients waiting for a kidney transplant in Italy, it is estimated that one in ten are classified as highly sensitized, with limited or no access to a suitable donor. Kidney transplant patients are classified as highly sensitized when they have pre-formed antibodies with a broad reactivity against human leukocyte antigens (HLAs), which can cause tissue damage and potentially transplant rejection. Due to the presence of these antibodies, finding a suitable donor organ for highly sensitized patients can be particularly difficult. As a result, highly sensitized patients spend longer than average on transplant waiting lists, and therefore have an increased risk of dying while waiting for a suitable donor.
“The positive decision by AIFA provides highly sensitized patients in Italy with an important opportunity to access a potentially lifesaving kidney transplant”, says Søren Tulstrup, President and CEO, Hansa Biopharma. “This decision is another step forward as we pursue our mission to develop innovative, lifesaving and life-altering therapies for patients with rare immunological diseases and conditions and generate value to society at large”.
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