OFICIAL Johnson & Johnson Newsroom

IMAAVY® (nipocalimab-aahu) demonstrates durable hemoglobin response and rapid onset of effect in pivotal Phase 2/3 study in warm autoimmune hemolytic anemia (wA

What happened
Based on Johnson & Johnson Newsroom · Jun 11, 2026

Johnson & Johnson’s IMAAVY (nipocalimab-aahu) showed durable hemoglobin improvement and rapid onset in a Phase 2/3 wAIHA study, with three times more responders than placebo by 24 weeks.

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Key points
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The randomized, placebo-controlled trial demonstrated approximately three times as many patients achieved durable Hgb levels versus placebo by 24 weeks.
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Overall, patients treated with this dose of IMAAVY showed a mean Hgb improvement of at least 1g/dL as early as Week 1.
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To be presented at the European Hematology Association (EHA) 2026 Congress, these results mark an important step forward for people living with wAIHA, a rare, life-threatening condition for which patients currently have no U.S.
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Food and Drug Administration (FDA)-approved treatment options.
Key numbers
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The 30 mg/kg dose group demonstrated approximately threefold more patients reaching durable hemoglobin targets by 24 weeks, with mean hemoglobin increases of at least 1 g/dL observed as early as Week 1.
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Primary endpoint required durable hemoglobin improvement meeting stringent criteria, including mean increase of 1 g/dL by Week 1 and maintenance of hemoglobin ≥10 g/dL with ≥2 g/dL increase from baseline by Week 24.
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IMAAVY also showed improvements in fatigue and reduced steroid use, with patient-reported fatigue changes noted as early as Week 2 and sustained through 24 weeks.

Johnson & Johnson presented Phase 2/3 ENERGY trial results at the EHA 2026 Congress showing IMAAVY (nipocalimab-aahu) achieved statistically significant durable hemoglobin response in patients with warm autoimmune hemolytic anemia (wAIHA) compared to placebo. The 30 mg/kg dose group demonstrated approximately threefold more patients reaching durable hemoglobin targets by 24 weeks, with mean hemoglobin increases of at least 1 g/dL observed as early as Week 1.

The randomized, double-blind, placebo-controlled ENERGY study enrolled 115 adults with wAIHA, randomized 1:1:1 to two IMAAVY dosing schedules or placebo. Primary endpoint required durable hemoglobin improvement meeting stringent criteria, including mean increase of 1 g/dL by Week 1 and maintenance of hemoglobin ≥10 g/dL with ≥2 g/dL increase from baseline by Week 24. Nearly two-thirds of patients in the 30 mg/kg group met both targets.

IMAAVY also showed improvements in fatigue and reduced steroid use, with patient-reported fatigue changes noted as early as Week 2 and sustained through 24 weeks. The safety profile aligned with prior studies in generalized myasthenia gravis, with common adverse reactions including peripheral edema, diarrhea, and fever. The trial supports a supplemental Biologics License Application granted U.S. FDA Priority Review.

wAIHA is a rare, life-threatening condition causing autoantibody-mediated destruction of red blood cells, with no FDA-approved treatments currently available. IMAAVY targets pathogenic IgG autoantibodies via FcRn blockade, preserving key immune functions while reducing disease-driving antibodies. The immunoselective approach aims to address unmet needs in wAIHA, where patients often rely on unapproved therapies such as corticosteroids and broad immunosuppressants.

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