Imlifidase

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.