- IMAAVY® is designed to block the neonatal Fc receptor (FcRn).
- wAIHA affects about 1 in 8,000 in the U.S. with no current treatments.
- Phase 2/3 ENERGY study shows improved hemoglobin and fatigue.
Background
Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for IMAAVY® (nipocalimab-aahu) as a treatment for warm autoimmune hemolytic anemia (wAIHA), a rare disease affecting about 1 in 8,000 people in the U.S. with no approved treatments.
Mechanism of Action
IMAAVY® works by selectively blocking the neonatal Fc receptor (FcRn), which is crucial for IgG recycling. This action reduces circulating IgG, including harmful autoantibodies, while preserving essential immune functions.
Clinical Study
The sBLA submission is backed by the Phase 2/3 ENERGY study, a multicenter, randomized, double-blind, placebo-controlled trial. The study demonstrated that more patients treated with nipocalimab achieved a durable hemoglobin response compared to placebo, defined as a hemoglobin level above 10 g/dL and an increase of at least 2 g/dL for at least 28 days without rescue therapy.
Results
In addition to hemoglobin improvement, patients treated with IMAAVY® showed rapid and sustained improvement in fatigue, a significant outcome for those living with wAIHA. The study results provide a strong rationale for IMAAVY®'s potential to improve fatigue and offer a durable hemoglobin response while maintaining favorable tolerability.
