Human Immunology Biosciences receives FDA orphan drug designation for felzartamab
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Key takeaways:
- Felzartamab would target and deplete CD38+ plasma cells.
- The investigational agent achieved positive outcomes in two phase 2 studies.
The FDA has granted orphan drug designation to felzartamab, an investigational agent being developed by Human Immunology Biosciences to treat primary membranous nephropathy, according to a press release.
The designation is an “acknowledgment of the critical and ongoing unmet need in [primary membranous nephropathy] PMN and the potential for felzartamab to be an important new therapeutic option to improve the lives of patients with PMN who currently have very limited treatment options,” Uptal Patel, MD, chief medical officer at Human Immunology Biosciences, said in the release. “We are excited to advance our clinical development program to make progress on our goal of transforming PMN into a well-managed condition.”
Felzartamab would specifically target and deplete CD38+ plasma cells believed to drive PMN by producing pathogenic autoantibodies. According to the release, felzartamab achieved positive outcomes in patients with PMN across two phase 2 studies, plus the agent is also in development for IgA nephropathy and antibody-mediated rejection of kidney transplants.
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