Johnson & Johnson’s IMAAVY nipocalimab-aahu has received FDA approval as the first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), based on durable hemoglobin response data from the Phase 2/3 ENERGY study.
Johnson & Johnson has shared late-breaking results from its Phase 2 JASMINE trial highlighting that nipocalimab achieves a sustained reduction in systemic lupus erythematosus (SLE) disease activity through 52 weeks.
Johnson & Johnson announces FDA Fast Track designation for nipocalimab in systemic lupus erythematosus. The immunoselective therapy demonstrated reduction in lupus disease activity in Phase 2 JASMINE study, offering potential steroid-sparing benefits and accelerated FDA review timeline.
