Posted by Michael Wonder on 03 Mar 2026
Johnson & Johnson therapy nipocalimab granted US FDA fast track designation in systemic lupus erythematosus
3 March 2026 - Johnson & Johnson today announced that nipocalimaba was granted US FDA fast track designation as a potential treatment for adults with systemic lupus erythematosus, a debilitating autoantibody-driven disease that impacts approximately 3 to 5 million people worldwide.
The designation is supported by a Phase 2 study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing.
