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 secured European Commission approval for Imaavy (nipocalimab), a novel treatment for generalized myasthenia gravis (gMG). This authorization marks the first FcRn blocker approved in Europe for a broad population that includes both adults and adolescents (aged 12+), offering a new option for sustained disease control.
IMAAVY demonstrated a swift and significant decrease in IgG levels, a primary driver of gMG, in key adult and pediatric trials.
