Hansa Biopharma has agreed with the FDA on a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients in the U.S.
Lund, Sweden December 13, 2019 Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced the outcome of a November 20th meeting with the U.S. Food and Drug Administration (FDA) to discuss a regulatory path forward for imlifidase in kidney transplantation of highly sensitized patients. Upon agreement with the FDA, following submission of a final study protocol, the Company will conduct a randomized, controlled clinical study in a limited group of highly sensitized kidney patients using a surrogate endpoint. Results from this clinical