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UPDATE: FDA Grants Fast Track Designation to Johnson & Johnson’s Investigational Therapy, Nipocalimab, for Adults with Systemic Lupus Erythematosus
The U.S. Food and Drug Administration (FDA) has granted Johnson & Johnson’s, nipocalimab, Fast Track designation as a potential treatment for adults with systemic lupus erythematosus (SLE). This status facilitates the expedited development and FDA drug review timeline, meaning that nipocalimab could become available sooner to treat adults with active SLE.
The Fast Track designation was supported by positive topline results from its Phase 2b JASMINE study, in which nipocalimab met its primary endpoint and key secondary and exploratory endpoints, demonstrating a meaningful reduction in lupus disease activity and potential for steroid sparing in adults with SLE. Nipocalimab is an immunoselective investigational therapy that lowers harmful immunoglobulin G (IgG), an abundant antibody in the immune system, which, in excess, can drive the immune system to attack healthy tissue. This is the fifth FDA Fast Track designation for Nipocalimab. Johnson & Johnson is currently enrolling adults with active SLE in the Phase 3 GARDENIA study to advance the drug.
Continue to follow the Lupus Foundation of America for updates on lupus drug developments and clinical trials. Learn more about treatments being studied for lupus.