Hansa closes on FDA verdict for transplant drug imlifidase
Hansa's chief executive, Renée Aguiar-Lucander.
The FDA has started a review of Hansa Biopharma's imlifidase for patients who need a kidney transplant, but for whom finding a donor is particularly challenging, with a decision due before the end of the year.
If approved, imlifidase will be the first treatment in the US that can improve the odds of highly "sensitised" patients having a successful kidney transplant, according to the Swedish biopharma company.
Around 10% to 15% of patients waiting for a kidney transplant are classed as "highly sensitised" – meaning they have very high antibody levels to human leukocyte antigens (HLAs), which makes it more likely they will reject a donated organ.
Compatible donors are therefore difficult to identify, and highly sensitised patients often endure significantly prolonged, and in some cases indefinite, waiting times, forcing them to remain dependent on long-term dialysis.
Imlifidase – which is already on the market in Europe and other markets around the world under the Idefirix brand name – is used to desensitise patients before transplant by dampening down the levels of HLA-directed antibodies.
Hansa had asked the FDA to consider a priority review of its biologics licensing application (BLA) for imlifidase, which was filed in December, but it appears that was turned down, setting back a decision date from August to 19th December this year.
The US ConfIdeS trial, which supported the filing, met its primary endpoint, showing significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate (eGFR) in highly sensitised adult kidney transplant patients compared to a control arm. It also increased the chances of patients living without the need for dialysis.
Sales of Idefirix, which claimed its first conditional approval in the EU in 2020, rose 46% to SEK 204 million ($22.1 million) last year, thanks to growing reimbursement levels in the EU, UK, and other markets like Switzerland and Australia, and showed signs of gathering momentum in the fourth quarter with a rise of 139% over the same period of 2024.
As in other markets, the FDA is reviewing the drug as an option for adult patients awaiting kidney transplantation with a positive crossmatch against an available deceased donor. With an estimated 100,000 people currently on the US transplant waiting list, approval by the FDA would lend additional momentum to imlifidase, which currently accounts for almost all of Hansa's revenues.
The company has already started building the infrastructure and resources required for a successful launch, hiring a head of US commercial, and intends to build a sales team of around 20 ahead of the FDA decision.
Hansa's chief executive, Renée Aguiar-Lucander, said the start of the FDA review and action date "marks an important milestone for Hansa Biopharma and for highly sensitised patients in the US awaiting kidney transplantation."
The company is also developing imlifidase as an enabling therapy for people undergoing gene therapy by preventing the formation of antibodies against the viral vectors used to deliver them, with encouraging initial results, although, a study in anti-glomerular basement membrane (anti-GBM) disease was negative.
