Imlifidase

Sensitization can follow pregnancy, blood transfusion, tissue grafting, or previous transplantation. Highly sensitized candidates are reported to comprise approximately 10–15% of transplant waiting lists across the United States and Europe. A United States allocation analysis found that candidates with CPRA of at least 99.9% continued to have lower transplant rates than the overall average despite national priority. Kidney failure affects daily activities, and in-center hemodialysis commonly requires three sessions per week, each lasting approximately four hours.

ConfIdeS was an open-label, randomized, controlled phase 3 trial involving 64 participants with cPRA of at least 99.9%. The sponsor reported mean eGFR at 12 months of 51.5 mL/min/1.73 m² with imlifidase and 19.3 mL/min/1.73 m² in the control arm, with p<0.0001. A subsequent sponsor presentation reported antibody-mediated rejection in 16 of 28 participants in the imlifidase arm and 6 of 13 in the control arm. These rejection denominators are not the full randomized population. The UK product information reports pneumonia in 5.6% and sepsis in 3.7% as the most common serious adverse reactions in the clinical studies supporting that document.

The Irish NCPE assessment includes a five-year budget-impact analysis, distinct from its lifetime cost-effectiveness model. The budget analysis assumed approximately 20 eligible patients and four to five imlifidase-enabled transplants annually. It estimated gross drug expenditure of €8,721,695 and a net total budget impact of €5,376,092 after other healthcare costs and dialysis cost offsets. These estimates describe the Irish population, prices, and model assumptions, not a United States budget impact.

Imlifidase has a conditional European authorization for selected highly sensitized adult kidney transplant candidates with a positive crossmatch against an available deceased donor. The United States BLA was accepted, with an announced FDA action date of December 19, 2026; the cited notice is not an approval. Treatment requires confirmation of crossmatch conversion, concomitant immunosuppression, and monitoring for rejection and infection. The randomized ConfIdeS results support improved 12-month kidney function in the studied population, but the reported rejection events and infection risks remain relevant to treatment selection and follow-up. Economic findings should be interpreted separately by jurisdiction and by model type.