SPRING HOUSE, PA — Johnson & Johnson (NYSE: JNJ) said the U.S. Food and Drug Administration has granted Priority Review to its supplemental Biologics License Application for IMAAVY (nipocalimab-aahu) to treat warm autoimmune hemolytic anemia, a rare, life-threatening blood disorder, shortening the review timeline to about six months.
Priority Review is reserved for therapies that may offer significant improvements in safety or effectiveness for serious conditions. Johnson & Johnson said this is the first therapy to receive the designation for warm autoimmune hemolytic anemia.
The application is supported by results from the Phase 2/3 ENERGY trial, which showed more patients receiving IMAAVY achieved a durable hemoglobin response compared with placebo, along with improvements in fatigue. Full data are expected to be presented at a medical meeting.
Warm autoimmune hemolytic anemia occurs when immunoglobulin G autoantibodies attack red blood cells, leading to anemia and increased risk of complications including thrombosis, kidney failure and infection. The condition affects about 1 to 3 people per 100,000 annually, with roughly 1 in 8,000 living with the disease.
There are no FDA-approved therapies specifically indicated for the condition, and treatment typically relies on corticosteroids, immunosuppressants and B-cell–targeted therapies.
IMAAVY works by blocking the neonatal Fc receptor, reducing circulating immunoglobulin G, including pathogenic autoantibodies, while preserving key immune functions.
“Warm autoimmune hemolytic anemia is a severe disease in which pathogenic immunoglobulin G antibodies drive destruction of red blood cells,” said Leonard L. Dragone, disease area leader for autoantibody and rheumatology at Johnson & Johnson.
IMAAVY is approved in the U.S. for generalized myasthenia gravis in patients 12 and older who are antibody positive for acetylcholine receptor or muscle-specific tyrosine kinase.
The therapy is being studied across multiple autoantibody-driven conditions, including rheumatologic, rare autoimmune and maternal-fetal diseases.
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