Johnson & Johnson (JNJ) has submitted a supplemental New Drug Application to the US FDA seeking approval of Imaavy (nipocalimab) for warm autoimmune hemolytic anemia.
The application is supported by data from the phase 2/3 ENERGY double-blind, placebo-controlled study that found more patients treated with Imaavy met the primary endpoint of durable hemoglobin response compared to placebo.
If approved, Imaavy would become the first treatment for the condition, which impacts 1 in 8,000 in the US.
Imaavy was approved in 2025 for generalized myasthenia gravis.
