Johnson & Johnson (JNJ) on Tuesday said its nipocalimab has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of adults with systemic lupus erythematosus, an autoimmune disease that causes inflammation throughout the body.
The designation is supported by positive Phase 2b JASMINE results, in which nipocalimab demonstrated a reduction in lupus disease activity and potential for steroid sparing.
A Phase 3 study dubbed GARDENIA evaluating nipocalimab in adults with active systemic lupus erythematosus is underway.
JNJ shares closed at $248.56 on Monday, up 0.05%.
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