Biogen Inc. (NASDAQ: BIIB) has secured breakthrough therapy designation (BTD) from the U.S. Food and Drug Administration (FDA) for felzartamab, an investigational anti-CD38 monoclonal antibody aimed at treating late antibody-mediated rejection (AMR) without T-cell mediated rejection in kidney transplant patients. This designation is pivotal as AMR is a leading cause of kidney transplant failure, and current treatment options are limited.
Felzartamab has previously received BTD and orphan drug designation for primary membranous nephropathy (PMN) and AMR in kidney transplant recipients. With Phase II studies completed for AMR, PMN, and IgA nephropathy (IgAN), Biogen is gearing up to initiate Phase III trials for all three indications in 2025.
Originally developed by MorphoSys AG, felzartamab was licensed to I-Mab for rights in China. In June 2022, Human Immunology Biosciences (HI-Bio) acquired exclusive rights to develop and commercialize the drug globally, excluding China. Biogen completed its acquisition of HI-Bio in July 2024, thereby obtaining exclusive rights to felzartamab outside of China.- Flcube.com
