Imlifidase (Idefirix) for Desensitization of highly sensitized adults before deceased-donor kidney transplant
The FDA is expected to decide on Imlifidase for Desensitization of highly sensitized adults before deceased-donor kidney transplant by December 19, 2026, under a BLA from Hansa Biopharma.
What is being decided
Hansa Biopharma has a BLA under FDA review for Imlifidase (Idefirix) in Desensitization of highly sensitized adults before deceased-donor kidney transplant. An enzyme from Streptococcus pyogenes, given as a single infusion hours before transplant, that cleaves IgG antibodies so a highly sensitized patient (cPRA 99.9% or higher, with a positive crossmatch) can receive a kidney that their immune system would otherwise reject immediately. These patients make up an estimated 10 to 15% of the transplant waiting list and can wait indefinitely on dialysis. Holds Fast Track and Orphan Drug designations; Hansa requested priority review but the FDA assigned a standard review with a December 19, 2026 action date. In the 64-patient US Phase 3 ConfIdeS trial, kidney function (eGFR) at 12 months was significantly better with imlifidase than in the control arm, and more patients were off dialysis. Would be the first US treatment for this group; conditionally approved in the EU and UK as Idefirix since 2020.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Frequently asked questions
When will the FDA decide on Imlifidase?
The FDA's target decision date (PDUFA date) for Imlifidase in Desensitization of highly sensitized adults before deceased-donor kidney transplant is December 19, 2026, disclosed by Hansa Biopharma. The agency can act before this date and occasionally runs past it.
What is Imlifidase being reviewed for?
Hansa Biopharma submitted a BLA for Imlifidase in Desensitization of highly sensitized adults before deceased-donor kidney transplant. An enzyme from Streptococcus pyogenes, given as a single infusion hours before transplant, that cleaves IgG antibodies so a highly sensitized patient (cPRA 99.9% or higher, with a positive crossmatch) can receive a kidney that their immune system would otherwise reject immediately. These patients make up an estimated 10 to 15% of the transplant waiting list and can wait indefinitely on dialysis. Holds Fast Track and Orphan Drug designations; Hansa requested priority review but the FDA assigned a standard review with a December 19, 2026 action date. In the 64-patient US Phase 3 ConfIdeS trial, kidney function (eGFR) at 12 months was significantly better with imlifidase than in the control arm, and more patients were off dialysis. Would be the first US treatment for this group; conditionally approved in the EU and UK as Idefirix since 2020.
What happens after the Imlifidase decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from Hansa Biopharma press release. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.