FDA Begins Review of Hansa Biopharma's BLA for Imlifidase in Kidney Transplantation
Hansa Biopharma AB has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase, seeking its use in desensitization of highly sensitized adult patients undergoing deceased donor kidney transplantation. The company has requested priority review, which, if granted, could lead to a six-month review cycle and potential approval as early as the third quarter of 2026. The application is supported by positive results from the pivotal US Phase 3 ConfIdeS trial and follows prior Fast Track and Orphan Drug Designations granted by the FDA.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hansa Biopharma AB published the original content used to generate this news brief via Cision (Ref. ID: 20251219:BIT:8524:0) on December 19, 2025, and is solely responsible for the information contained therein.