Sep 25, 2019
Lund, Sweden September 25, 2019. Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG-mediated diseases, today announced that a date for a follow- up meeting with the U.S. Food and Drug Administration (FDA) has now been confirmed. The meeting will take place on November 20th, 2019.
At the upcoming meeting with the FDA, Hansa Biopharma intends to continue the discussion from December 2018 regarding the path forward for a regulatory filing of imlifidase in kidney transplantation of highly sensitized patients in the U.S.
During the initial FDA meeting in December 2018, the agency provided positive feedback on the phase 2 data generated on imlifidase and acknowledged the high unmet medical need of highly sensitized patients for whom it is extremely difficult to access kidney transplantation.
Following the 2018 meeting, Hansa Biopharma has conducted complementary analyses to further illustrate the value that imlifidase brings to highly sensitized patients, also in the context of the US Kidney Allocation System (KAS).
Hansa Biopharma expects to receive minutes from the FDA meeting before end-of-December 2019.