FDA approves first therapy for warm autoimmune hemolytic anemia - Report - MDSpire
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FDA approves first therapy for warm autoimmune hemolytic anemia

The phase 2/3 ENERGY trial evaluated durable hemoglobin response with nipocalimab vs placebo in adults with warm autoimmune hemolytic anemia.

  • By

  • Kathryn Wighton

  • August 25, 2026

  • 3 min

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Clinical Report: FDA approves first therapy for warm autoimmune hemolytic anemia

Overview

The FDA has approved nipocalimab-aahu (IMAAVY) as the first therapy for warm autoimmune hemolytic anemia (wAIHA) in patients aged 12 and older. This approval is based on the results of the phase 2/3 ENERGY trial, which demonstrated efficacy in improving hemoglobin levels compared to placebo.

Background

Warm autoimmune hemolytic anemia (wAIHA) is characterized by the destruction of red blood cells due to autoantibodies, leading to anemia and increased risk of complications.

Data Highlights

GroupDurable Hemoglobin ResponseMean Hemoglobin Change at Week 1Mean Change in Fatigue Score at Week 24
Nipocalimab 30 mg/kg23.7% (9/38)1 g/dL3.5 points
Nipocalimab 15 mg/kg21.1% (8/38)--
Placebo7.7% (3/39)--

Key Findings

  • Nipocalimab-aahu is the first FDA-approved therapy specifically for wAIHA.
  • The approval was based on the phase 2/3 ENERGY trial involving 115 adults.
  • Participants receiving nipocalimab had a significantly higher durable hemoglobin response compared to placebo.
  • Mean hemoglobin levels increased by 1 g/dL at week 1 for the 30 mg/kg dose group.
  • Common adverse reactions included peripheral edema, diarrhea, and fever.

Clinical Implications

Clinicians should be aware of the potential adverse effects and monitor patients accordingly.

Conclusion

The approval of nipocalimab represents a milestone in the management of warm autoimmune hemolytic anemia.

Related Resources & Content

  1. Johnson & Johnson, Investor News, 2026 -- FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA)
  2. Johnson & Johnson, JNJ Medical Connect, 2026 -- Nipocalimab for warm autoimmune hemolytic anemia: results from the phase 2/3 randomized trial
  3. MDSpire News — FDA Approves Treg Cell Therapy
  4. the asco post — FDA Approves First Treatment for Patients With Rare Congenital Blood Disorder
  5. the medicine maker — This Week's CGT News: First Treg Therapy Approved
  6. The ASCO Post — FDA Approves Immunotherapy to Reduce Chronic GVHD in Patients Undergoing Stem Cell Transplant
  7. FDA approves IMAAVY® (nipocalimab-aahu) as first-ever treatment for warm autoimmune hemolytic anemia (wAIHA), representing a landmark advancement for patients | Johnson & Johnson
  8. https://www.jnjmedicalconnect.com/media/attestation/congresses/immunology/2026/eha/nipocalimab-for-warm-autoimmune-hemolytic-anemia-results-from-the-phase-23-rando.pdf
  9. Diagnosis and treatment of autoimmune hemolytic anemia in adults: Recommendations from the First International Consensus Meeting - PubMed

Original Source(s)

FDA approves first therapy for warm autoimmune hemolytic anemia

  • by Kathryn Wighton

  • August 25, 2026

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