Announcement • Aug 25

Johnson & Johnson Receives FDA Approval For IMAAVY (Nipocalimab-Aahu) As First Treatment For Warm Autoimmune Hemolytic Anemia

Johnson & Johnson announced the U.S. Food and Drug Administration (FDA) approval of IMAAVY® (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia (wAIHA) in adults and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. IMAAVY is an immunoselective FcRn blocker designed to target and reduce pathogenic immunoglobulin G (IgG) autoantibodies while also preserving B-cell function. Warm autoimmune hemolytic anemia is a rare, life-threatening disease in which autoantibodies cause the destruction of red blood cells, leading to severe anemia and debilitating fatigue. The approval is based on the pivotal Phase 2/3 study which demonstrated durable hemoglobin response. A mean increase in hemoglobin of 1 g/dL at Week 1 and improvement in FACIT-Fatigue score at Week 24 were observed in IMAAVY-treated patients. In wAIHA, pathogenic immunoglobulin G (IgG) autoantibodies attach to and destroy red blood cells, causing severe anemia, profound fatigue, and a significantly increased risk of morbidity and mortality. Previously, available treatment options only included corticosteroids and immunosuppressants — therapies that suppress the entire immune system without specifically targeting the IgG autoantibodies driving the disease. The primary endpoint of the Phase 2/3 ENERGY study was durable hemoglobin (Hgb) response, a stringent endpoint definition that reflects meaningful increases in Hgb levels over time. The randomized, placebo-controlled trial demonstrated approximately three times as many patients receiving the approved dose of IMAAVY achieved durable Hgb levels versus placebo by 24 weeks. Overall patients in this treatment group showed a mean increase in Hgb of 1g/dL at Week 1. In addition, IMAAVY was associated with a 3.5-point higher mean FACIT-Fatigue score versus placebo at Week 24, with higher scores defined as less fatigue. In the ENERGY study IMAAVY demonstrated a safety profile consistent with the established safety profile of IMAAVY in generalized myasthenia gravis (gMG). The most common adverse reactions (=10%) in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea, and fever. The full results of the ENERGY study were presented at the European Hematology Association 2026 meeting in June 2026. IMAAVY was approved in the United States in April 2025 for the treatment of gMG in adult and pediatric patients 12 years of age and older who are acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive. Once a decision has been made to prescribe IMAAVY, the IMAAVY withMe patient support program provides personalized support including educational resources, a dedicated Nurse Navigator, and cost support options – regardless of insurance type. Durable hemoglobin (Hgb) response, the primary endpoint of the Phase 2/3 ENERGY trial, is defined as Hgb concentration =10 g/dL and an increase from baseline in Hgb =2 g/dL for at least 28 days (where criteria was met starting by Week 16 of the double-blind period), without the need of rescue therapy. A mean increase of 1 g/dL in Hgb was observed at Week 1. Among the responders, the median time to first Hgb response was 4.1 (range: 1 to 12) weeks in patients treated with IMAAVY 30 mg/kg every 4 weeks, compared to 12.1 (range: 4 to 16) weeks in the placebo group. Results are considered descriptive based on the study's pre-specified statistical analysis plan. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue). Mean change from baseline of FACIT-Fatigue score at Week 24, a key secondary endpoint, with mean difference of 3.51 (95% CI: 0.64; 6.39) points in the IMAAVY 30 mg/kg IV treatment group compared to placebo. Results are considered descriptive based on the study's pre-specified statistical analysis plan. 30 mg/kg q4w is the approved dose. Durable Hgb response, as defined in Editor's note "a," was achieved with statistical significance in the approved 30 mg/kg IV q4w treatment group. Nurse Navigators do not provide medical advice. ENERGY (NCT04119050) is a multicenter, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating the efficacy and safety of nipocalimab compared with placebo, followed by an open-label extension period, in adults living with warm autoimmune hemolytic anemia (wAIHA). 115 adults were randomized approximately 1:1:1 to receive nipocalimab at two different dose schedules or placebo. Following completion of 24 weeks of double-blind treatment, patients could enter an open-label extension period to receive nipocalimab for 144 weeks with a follow-up period of 6 weeks after last assessment. Warm autoimmune hemolytic anemia (wAIHA) is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells (RBCs), resulting in anemia. Approximately 1-3 new people per 100,000 are affected by wAIHA per year, and about 1 in 8,000 individuals are living with the condition. This condition affects both women and men, and can affect people at any age with incidence increasing over the age of 50. Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection. IMAAVY® is an immunoselective treatment designed to target, bind with high affinity, and block the neonatal Fc receptor (FcRn), reducing circulating immunoglobulin G (IgG) antibodies that drive disease while also preserving B-cell function based on in vitro and/or in vivo studies. IMAAVY is currently approved for the treatment of generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

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