The U.S. Food and Drug Administration has approved Johnson & Johnson’s Imaavy, or nipocalimab-aahu, for adults and pediatric patients aged 12 and older with warm autoimmune hemolytic anemia who are currently receiving or previously received corticosteroids. The Priority Review decision makes Imaavy the first therapy specifically proven safe and effective for the rare, life-threatening disorder, in which IgG autoantibodies destroy red blood cells. In the Phase 2/3 ENERGY study, about three times as many patients receiving the approved dose achieved a durable hemoglobin response by Week 24 as those given placebo. Imaavy also produced a mean hemoglobin increase of 1 gram per deciliter at Week 1 and a 3.5-point higher mean FACIT-Fatigue score than placebo at Week 24. The drug was first approved in April 2025 for certain patients aged 12 and older with generalized myasthenia gravis who are positive for acetylcholine receptor or muscle-specific kinase antibodies. Johnson & Johnson shares were down 0.33% at $270.81 in premarket trading Tuesday, near a 52-week high of $276.47.