Johnson & Johnson wins FDA approval for IMAAVY

• Johnson & Johnson (NYSE:JNJ) received U.S. FDA approval for IMAAVY (nipocalimab-aahu) as a treatment for warm autoimmune hemolytic anemia.
• The approval followed Phase 2/3 ENERGY trial results showing more patients achieved durable hemoglobin response compared with placebo.
• The company is expanding IMAAVY’s use in autoimmune diseases following prior clinical development in generalized myasthenia gravis.

Johnson & Johnson (NYSE:JNJ) received U.S. Food and Drug Administration approval for IMAAVY (nipocalimab-aahu) as the first treatment specifically approved for warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients aged 12 years and older.

The approval follows results from the Phase 2/3 randomized, placebo-controlled ENERGY trial, where patients receiving the approved 30 mg/kg intravenous dose every four weeks showed a higher rate of durable hemoglobin response compared with placebo by Week 24.

In the trial, approximately three times as many patients receiving IMAAVY achieved durable hemoglobin response compared with placebo, while treated patients recorded a mean hemoglobin increase of 1 g/dL at Week 1 and a 3.5-point higher mean FACIT-Fatigue score at Week 24.

Johnson & Johnson stated that the safety profile of IMAAVY in wAIHA was consistent with previous experience in generalized myasthenia gravis, with common adverse reactions including peripheral edema, diarrhea, and fever.

The approval adds another indication for nipocalimab, a medicine designed to block neonatal Fc receptor activity, as Johnson & Johnson continues developing treatments for immune-mediated diseases.

Johnson & Johnson’s pharmaceutical business includes medicines across areas such as immunology, oncology, neuroscience, and cardiovascular disease, with IMAAVY forming part of its autoimmune disease portfolio.