BRIEF—Hansa Biopharma MMA for Idefirix accepted for review

Sweden’s Hansa Biopharma says that the European Medicines Agency has accepted the company's Marketing Authorization Application (MAA) for review of Idefirix (imlifidase).

Hansa is seeking approval of Idefirix as a treatment to enable kidney transplantation in highly sensitized patients.

Idefirix is a novel antibody-degrading enzyme that eliminates immunological barriers that 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 February 5, 2019 and marks the beginning of the regulatory review process for Idefirix in the European Union (EU).

Idefirix 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).

The dialogue with the US Food and Drug Administration to determine the path forward for regulatory approval is ongoing and Hansa will provide updated guidance regarding expected timeline for a Biologic License Application filing in the upcoming months.

The FDA has granted Idefirix Orphan Drug Designation and Fast Track Designation in kidney transplantation.