Hansa Biopharma submits responses to outstanding questions from EMA for imlifidase application in kidney transplantation.

Hansa Biopharma, the leader in immunomodulatory enzyme technology for rare IgG mediated diseases, announced that the ongoing EMA review of imlifidase for a potential marketing authorization in Europe is on track. A CHMP opinion is expected at the June 22-25 meeting, followed by a decision by the European Commission in Q3 2020.

At the CHMP meeting on April 28-30 a list of outstanding issues was adopted, including definition of patient population and design of the post approval study. A one-month clock-stop was initiated to enable Hansa Biopharma to address the outstanding issues. The Company will submit a comprehensive response on May 26 and expect an opinion from CHMP following the June 22-25 meeting .The Marketing Authorization Application for imlifidase in kidney transplantation was accepted for review by the European Medicines Agency on 28 February. 2019.