Johnson & Johnson reported that the U.S. FDA granted Fast Track designation to nipocalimab as a potential treatment for adults with systemic lupus erythematosus. The designation is supported by results from the Phase 2b JASMINE study, a 52-week randomized, double-blind, placebo-controlled trial in 228 adults with active SLE, in which nipocalimab demonstrated a reduction in lupus disease activity and potential steroid-sparing effects. Johnson & Johnson also said it has initiated enrollment and is actively enrolling patients in the Phase 3 GARDENIA study in adults with active SLE. The Phase 2b results have already been presented as positive, and no future presentation timing was specified in the announcement.

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