The Scottish Medicines Consortium (SMC) Recommends Use of Hansa Biopharma’s Idefirix® (Imlifidase) as Desensitization Treatment for Highly Sensitized Kidney Transplant Patients

Hansa Biopharma, “Hansa” (Nasdaq Stockholm: HNSA), a pioneer in enzyme technology for rare immunological conditions, today announce the recommendation by the Scottish Medicines Consortium (SMC) for its first-in-class treatment Idefirix® in the desensitization of highly sensitized adult patients prior to kidney transplant from a deceased donor. The SMC considers Idefirix® to be a clinically effective and cost-effective treatment and recognizes the significant unmet need of the licensed patient population it treats. 1

The recommendation marks an important milestone for patients in Scotland, as 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. Kidney transplant candidates are classified as highly sensitized if they have a broad and intense range of pre-formed antibodies against almost all donor organs. These anti-bodies are known as human leukocyte antigens (HLAs) Finding a match for these patients can be particularly difficult, leading to a longer average time on transplant waiting lists, and therefore have an increased risk of dying while waiting for a suitable donor.6,7

The approval of Idefirix® offers a new option to these highly sensitized patients in need of transplant to increase the chances of successful matching with a deceased donor organ.

Dr Adnan Sharif, trustee at Kidney Research UK welcomed the decision, saying “A lack of effective desensitization approaches has meant that until now, people who are classed as highly sensitized kidney patients have struggled to find a donor match, and have often had no alternative but to remain on long-term dialysis with a very poor quality of life. It is fantastic to see that the SMC has followed the direction of England and Wales to offer certain highly sensitized patients the opportunity of a life-altering transplant. The decision making around who has access to the treatment is key, and the lifespan of the transplanted kidneys will need to be carefully monitored. But success could see many patients gain freedom from gruelling dialysis treatments”.

“We are thrilled that the SMC has recommended Idefirix® as the first licensed therapy for highly sensitized kidney patients in Scotland. These patients have serious disease burden and unmet needs, and this recommendation is a significant milestone for them”, says Søren Tulstrup, President and CEO, Hansa Biopharma. “For Hansa, this recommendation is also encouraging as we continue to pursue our vision: A world where patients with rare immunologic diseases can lead long and healthy lives”.

Hansa will work closely with Scottish health boards to support the implementation of the service in line with the SMC’s recommendations.