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# FDA Orphan Drug Status for Felzartamab
- URL: https://www.fdaweb.com/fda-orphan-drug-status-for-felzartamab/
- Published: 2023-05-25T12:00:00.000Z
- Updated: 2026-09-14T18:34:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154541

FDA has granted Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropathy (PMN). The monoclonal antibody is designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies, the company says.

PMN is a rare immune-mediated disease affecting the kidneys of more than 36,000 people in the United States. The company says there are currently no approved therapies for PMN, and standard of care comprises immunosuppressive therapies like cyclophosphamide and CD20-targeted B-cell depleting agents. “Even with these strategies, half of patients with PMN continue to have nephrotic syndrome and nearly one third progress to kidney failure,” Human Immunology Biosciences says.

Two recently [announced](https://c212.net/c/link/?t=0&l=en&o=3875553-1&h=4087527304&u=https%3A%2F%2Fhibio.com%2Fnews%2Fhi-bio-announces-positive-phase-2-data-on-felzartamab-for-the-treatment-of-primary-membranous-nephropathy&a=announced&ref=fdaweb.com) studies showed that elzartamab produced a dose-dependent reduction in pathogenic antibody levels, according to the company. Felzartamab is also being evaluated in investigator-initiated studies for PMN in patients who have had inadequate response to anti-CD20 and for antibody mediated rejection of renal allograft transplants.