SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said it has submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration seeking approval of IMAAVY (nipocalimab-aahu) as a treatment for warm autoimmune hemolytic anemia.
The company said the application is supported by data from the Phase 2/3 ENERGY clinical trial evaluating the therapy in adults with the rare autoimmune condition.
Warm autoimmune hemolytic anemia occurs when immunoglobulin G autoantibodies attach to and destroy red blood cells, leading to anemia.
Johnson & Johnson said the disease affects about 1 in 8,000 people in the United States and currently has no FDA-approved treatments.
According to the company, results from the ENERGY trial showed more patients treated with nipocalimab achieved a durable hemoglobin response compared with those receiving a placebo.
A durable response was defined in the study as maintaining a hemoglobin level above 10 grams per deciliter and an increase of at least 2 grams per deciliter for at least 28 days without rescue therapy.
David M. Lee, global immunology therapeutic area head at Johnson & Johnson, said the application represents a milestone for patients with the condition.
“People living with warm autoimmune hemolytic anemia face a serious, life-threatening disease with no approved treatment options and a high risk of complications,” Lee said.
IMAAVY works by blocking the neonatal Fc receptor, which regulates immunoglobulin G recycling, according to the company. By reducing circulating IgG antibodies, the treatment is intended to address the autoimmune process that leads to red blood cell destruction.
Johnson & Johnson said patients treated with the therapy in the ENERGY trial also showed improvement in fatigue, as measured using the FACIT-Fatigue assessment.
Bruno Fattizzo, assistant professor in the Department of Oncology and Hematology-Oncology at the University of Milan, said the trial results demonstrated clinically meaningful outcomes.
“These results provide a strong rationale for the potential of IMAAVY to rapidly improve fatigue and provide durable hemoglobin response while maintaining favorable tolerability,” Fattizzo said.
IMAAVY was approved in the United States in April 2025 for treating generalized myasthenia gravis in patients aged 12 and older who test positive for certain antibodies.
Johnson & Johnson said full results from the ENERGY study are expected to be released in the future.
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