Biogen (Ticker: BIIB) has announced that the FDA has granted Breakthrough Therapy Designation to felzartamab for treating late antibody-mediated rejection (AMR) in kidney transplant patients, specifically those not exhibiting T-cell mediated rejection. This designation offers Biogen enhanced engagement opportunities with the FDA and supports the drug’s development program through Fast Track benefits. The company intends to launch Phase 3 trials for felzartamab in 2025, targeting conditions such as AMR, IgA nephropathy (IgAN), and primary membranous nephropathy (PMN).
Originally developed by MorphoSys for multiple myeloma, felzartamab's development and commercialization rights (except in China) now belong to HI-Bio. Biogen completed its acquisition of HI-Bio in July 2024, securing these rights.
