Posted by Michael Wonder on 31 Oct 2023
HI-Bio announces felzartamab granted breakthrough therapy designation by US Food and Drug Administration for primary membranous nephropathy
31 October 2023 - Human Immunology Biosciences today announced that the US FDA has granted breakthrough therapy designation for felzartamab in primary membranous nephropathy.
The designation for felzartamab was based on clinical data submitted to the FDA, including results from M-PLACE, a Phase 1b/2a proof of concept, open-label, study.
