NICE (UK) recommends use of Idefirix as desensitization treatment for highly sensitized kidney transplant patients.
Hansa Biopharma, announces the recommendation by the National Institute for Health and Care Excellence (NICE) for its first-in-class treatment Idefirix in the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor.
NICE considers Idefirix to be a clinically and cost-effective treatment. The recommendation marks an important milestone for patients in England, Wales and Northern Ireland, as appropriate specialized transplant centres will be able to use Idefirix to enable transplantation for highly sensitized patients, currently highly unlikely to receive a lifesaving compatible kidney transplant.
The Medicines and Healthcare products Regulatory Agency’s (MHRA) granted conditional approval of imlifidase from the European Commission conditional approval in August 2020.
Kidney transplant candidates are classified as highly sensitized if they have pre-formed antibodies against available donors known as human leukocyte antigens (HLA). These antibodies can carry the risk of causing damage to the transplanted kidney and potentially lead to rejection. Risk factors for becoming highly sensitized include previous transplantation, blood transfusion and pregnancy. Finding a match for these patients can be particularly difficult, meaning they spend a longer average time on transplant waiting lists, and therefore have an increased risk of dying while waiting for a suitable donor. The annual average number of kidney transplants in the U.K. over the last five years are 2,400 from deceased donors and 926 from living donors.
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