IMAAVY (nipocalimab-aahu) - (ENERGY)

Aug. 24, 2026: Johnson & Johnson (NYSE: JNJ) said the FDA approved IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients age 12+ who are currently or were previously treated with corticosteroids. The company says this is the first FDA-approved therapy specifically for wAIHA; the review had Priority Review.

Approval was based on the Phase 2/3 ENERGY trial (NCT04119050), a randomized, double-blind, placebo-controlled study in 115 adults. The primary endpoint, durable hemoglobin response, was achieved with statistical significance in the approved 30 mg/kg IV every-4-weeks group; the release says about three times as many patients achieved durable hemoglobin response versus placebo by 24 weeks. Durable response was defined as hemoglobin at least 10 g/dL and at least a 2 g/dL increase from baseline for at least 28 days without rescue therapy. Mean hemoglobin increased 1 g/dL at Week 1, median time to first hemoglobin response among responders was 4.1 weeks versus 12.1 weeks for placebo, and FACIT-Fatigue improved by 3.51 points versus placebo at Week 24 (95% CI: 0.64-6.39). Common adverse reactions in wAIHA were peripheral edema, diarrhea, and fever. Full ENERGY results were presented at EHA 2026 in June 2026.