Name: Imlifidase in Kidney transplantation in highly sensitized patients: Phase of product development
Published: 2026-09-14T15:39:06-04:00

Product information and disease description Product description

Phase of product development

6 evidence topics · 5 sources

FDA submission and designations

“the submission of a Biologics License Application (BLA)” (opens the source at this quote in a new tab)
“FDA has granted Hansa Biopharma Fast Track and Orphan Drug Designation and Hansa has requested Priority Review” (opens the source at this quote in a new tab)

Regulatory submission: BLA submitted December 2025

“Lund, Sweden, 19 December 2025.” (opens the source at this quote in a new tab)
“today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase.” (opens the source at this quote in a new tab)

FDA acceptance

“Hansa Biopharma’s Biologics License Application (BLA) for imlifidase accepted by the FDA” (opens the source at this quote in a new tab)

PDUFA action date

“December 19, 2026” (opens the source at this quote in a new tab)

Launch: Anticipated in the first quarter of 2027

“Imlifidase Potentially Available in Q1 2027*” (opens the source at this quote in a new tab)
“*Subject to FDA Approval” (opens the source at this quote in a new tab)

European authorization

“Idefirix received a conditional marketing authorisation valid throughout the EU on 25 August 2020.” (opens the source at this quote in a new tab)