Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Tuesday that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration (FDA) for approval of IMAAVY (nipocalimab-aahu) as the first-ever treatment for patients with warm autoimmune haemolytic anaemia (wAIHA).

wAIHA is a rare, life-threatening condition where autoantibodies attach to and destroy red blood cells, resulting in anaemia. Additionally, people with wAIHA are at increased risk of other serious complications such as venous thrombotic events, acute renal failure, and infection. It affects approximately 1 in 8,000 people in the United States.

The sBLA submission is supported by the Phase 2/3 ENERGY multicentre, randomised, double-blind, placebo-controlled study evaluating IMAAVY in adults living with wAIHA. Data showed that more patients treated with nipocalimab achieved the stringent primary endpoint of a durable haemoglobin response compared with placebo.