HI-Bio™ Receives FDA Orphan Drug Designation for Felzartamab in Treatment of Rare Kidney Disease, Paving the Way for Late-Stage Studies
Human Immunology Biosciences (HI-Bio™), a clinical-stage biotech company focusing on severe immune-mediated diseases (IMDs), has been granted orphan drug designation (ODD) by the FDA for felzartamab. This investigational monoclonal antibody targets primary membranous nephropathy (PMN) by depleting CD38+ plasma cells responsible for producing harmful autoantibodies. With no approved therapies for PMN, felzartamab offers hope for the 36,000 affected individuals in the US. Positive Phase 2 results have also been achieved, motivating HI-Bio™ to explore felzartamab's potential in other IMDs. The FDA's ODD program provides development incentives to advance treatments for rare conditions.
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