Regulatory UK’s NICE makes recommendation for Imlifidase by Hansa Biopharmaceutical

UK’s NICE makes recommendation for Imlifidase by Hansa Biopharmaceutical


With the National Institute for Health and Care Excellence’s (NICE) recommendation for the use of imlifdase, over 100 kidney transplant recipients will be eligible to receive treatment in the region of Wales and England. 

Imlifidase or Idefirix is used to desensitize recent kidney transplant recipients who are highly sensitized and have received the organ from a deceased donor. 

The UK National Institute for Health and Care Excellence (NICE) has recommended Hansa Biopharma’s imlifidase (Idefirix) for the desensitization of highly sensitized adults before a kidney transplant from a deceased donor. Essentially, imlifidase is an enzyme that prevents the rejection of the transplanted kidney by the recipient’s immune system.

The enzyme works by neutralizing the immunoglobulin G (IgG) antibody that responds to the presence of a foreign body in humans. The antibody’s function is to protect against the foreign/harmful substance but can react to the transplanted organ causing its rejection.

NICE refers the use of Hansa Biopharma Idefirix as a treatment for those individuals that are likely to reject the transplanted organ due to high sensitivity to human leukocyte antigens (HLAs). This HLAs sensitivity leads to these individuals having less success with their kidney transplantation.

The recommendation for Hansa Biopharma’s therapy is made considering a number of factors in consideration, which include clinical efficacy, cost-effectiveness and the need for the therapy in the market. 

NICE expressed its positive opinion about Hansa Biopharma’s imlifdase and a director stated that the treatment option is intended for those highly sensitive patients that have been on the waitlist for a kidney transplant for a long time, often on dialysis waiting for a transplant. Through imlifdase their quality of life can be improved as the chances of rejection of the transplanted kidney decreases. 

It was found in clinical trials that when imlifidase was given to patients before their kidney transplant took place, their immune system was less likely to reject the organ through immunoglobulin G (IgG). The clinical trial was conducted over the course of three years and found these results in patients belonging to the highly-sensitized subset. 

Thus, the treatment is able to provide kidney transplant recipients with greater chances of success and improved quality of life, allowing highly-sensitive patients to be able to receive the life-saving kidney transplant with similar results as other groups. 

CEO of Hansa Biopharma explained the company’s excitement at imlifidase’s recommendation by NICE and stated that this is the first treatment option to be licensed for highly sensitized kidney patients.

A Kidney Research UK trustee commented: “We welcome this decision, which will allow new opportunities for certain highly sensitized patients to qualify for a life-altering transplant and gain freedom from dialysis. Decision making around who has access to the treatment is key, and the lifespan of the transplanted kidneys will need to be carefully monitored.”

Health and Social Care Secretary in the UK exclaimed that this news of imlifidase is highly encouraging for kidney transplant hopefuls, giving them hope for the success of their transplants. He welcomed NICE’s decision and stated that this drug would be able to impact the quality of life of patients positively and is a great treatment option for eligible adults.

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