1 March 2019 - Hansa Biopharma announced today that the EMA has accepted the company's marketing authorisation application for review of Idifirix (imlifidase). 

Hansa is seeking approval of Idifirix as a treatment to enable kidney transplantation in highly sensitised patients. Idefirix is a novel antibody-degrading enzyme that eliminates immunological barriers. It is administered as a single intravenous infusion immediately prior to transplantation and rapidly inactivates donor specific antibodies (DSAs).

This acceptance follows Hansa's submission of the MAA on 5 February 2019 and marks the beginning of the regulatory review process for Idefirix in the European Union (EU). Idifirix has both EU Orphan Drug Designation and PRIority MEdicine (PRIME) designation, an EMA program to enhance support for the development of medicines that target an unmet medical need. An opinion of the Committee for Medicinal Products for Human Use (CHMP) is expected within 210 days (plus any clock-stops for the applicant to provide answers to questions which may arise during the review). After the adoption of a CHMP opinion, a final decision regarding the MAA for Idefirix is made by the European Commission.

Read Hansa Medical press release