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T cell-regulating therapies for autoimmune diseases take FDA rejection in stride
Despite a regulatory setback for Provention Bio’s diabetes prevention candidate teplizumab, hopes remain high for T cell-regulating therapies in autoimmune indications including multiple sclerosis, systemic lupus erythematosus and coeliac disease.
Teplizumab, an anti-CD3 antibody that Provention Bio is developing to delay type 1 diabetes (T1D) in at-risk individuals, has spent an unusually long time in development. Precursors of the antibody date back to the 1970s, and teplizumab has been in and out of clinical trials since 1997. With the FDA’s rejection of the antibody in July 2021, the journey continues.