The FDA has granted Orphan Drug Designation to felzartamab, an investigational therapeutic human monoclonal antibody, for the treatment of antibody-mediated rejection (AMR) in individuals who have received a kidney transplant. Developed by Human Immunology Biosciences (HI-Bio), felzartamab selectively depletes CD38+ plasma cells, improving clinical outcomes in various diseases. Uptal Patel, MD, the chief medical officer at HI-Bio, expressed excitement about the designation and the potential of the anti-CD38 cellular depletion strategy.
Felzartamab has also received breakthrough therapy designation for primary membranous nephropathy (PMN), a serious condition where there is a need for major advancements in available therapies. The drug has shown promising results in PMN trials, and HI-Bio is developing felzartamab for multiple diseases, including PMN, IgA nephropathy, AMR, and lupus nephritis. Orphan drug designation is assigned to drugs intended to treat rare diseases affecting fewer than 200,000 individuals, while breakthrough designation expedites the development and review of drugs for serious or life-threatening conditions.
The FDA’s recognition of felzartamab’s potential is based on positive data collected thus far, and HI-Bio plans to submit clinical data from the ongoing study of felzartamab in AMR to a medical conference this year. This designation marks a significant step towards the development and approval of felzartamab as a breakthrough therapy for AMR and PMN, offering hope for patients in need of improved treatment options in these challenging conditions.
References:
1. HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Antibody-Mediated Rejection (AMR) in Kidney Transplant Recipients. HI-Bio News Release. March 21, 2024.
2. HI-Bio Receives FDA Orphan Drug Designation for Felzartamab for the Treatment of Membranous Nephropathy. HI-Bio News Release. May 25, 2023.
3. HI-Bio Announces Positive Phase 2 Data on Felzartamab for the Treatment of Primary Membranous Nephropathy. HI-Bio News Release. April 11, 2023.
4. HI-Bio Announces Felzartamab Granted Breakthrough Therapy Designation by U.S. Food and Drug Administration for Primary Membranous Nephropathy (PMN). HI-Bio News Release. October 31, 2023.
