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# Hansa Biopharma’s Imlifidase Hits Primary Endpoint
- URL: https://www.fdaweb.com/hansa-biopharmas-imlifidase-hits-primary-endpoint/
- Published: 2025-09-25T12:00:00.000Z
- Updated: 2026-09-14T15:22:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159934

Hansa Biopharma says investigational imlifidase met the primary endpoint in a pivotal Phase 3 study in highly sensitized kidney transplant patients, setting up a potential U.S. regulatory filing later this year. The U.S.-based ConfIdeS trial enrolled adults with a calculated panel reactive antibody level of 99.9% or higher — patients considered among the hardest to match for kidney transplants. At 12 months, patients treated with imlifidase achieved a mean estimated glomerular filtration rate of 51.5 mL/min/1.73m² compared with 19.3 mL/min/1.73m² in the control group, according to the company. The 32.2 mL difference was both statistically significant and clinically meaningful, it adds.

Additionally, Hansa says imlifidase was also associated with a higher rate of dialysis independence at 12 months. Safety results were consistent with previous studies, with no unexpected findings, it says.

Based on the data, Hansa plans to submit a BLA under the accelerated approval pathway by the end of 2025.