Johnson & Johnson Wins FDA Approval for IMAAVY in wAIHA

Johnson & Johnson has received U.S. Food and Drug Administration (FDA) approval for IMAAVY® (nipocalimab-aahu) to treat warm autoimmune haemolytic anaemia (wAIHA) in adults and paediatric patients aged 12 years and older who are currently or previously treated with corticosteroids.

The approval follows an FDA Priority Review and provides the first specifically approved treatment for wAIHA supported by clinical evidence demonstrating safety and efficacy.

wAIHA is a rare autoimmune disorder in which IgG autoantibodies attack and destroy red blood cells, resulting in anaemia, severe fatigue and an increased risk of serious complications. 

Existing treatment has largely relied on corticosteroids and immunosuppressive medicines, which suppress immune activity more broadly.

The approval is supported by results from the Phase 2/3 ENERGY study, a randomised, placebo-controlled trial. 

Patients receiving the approved dose of IMAAVY were approximately three times more likely to achieve a durable haemoglobin response by Week 24 than those receiving placebo.

The treatment group also recorded an average haemoglobin increase of 1 g/dL by Week 1.

At Week 24, IMAAVY was associated with a 3.5-point improvement in mean FACIT-Fatigue scores compared with placebo.
 
The most common adverse reactions were peripheral oedema, diarrhoea and fever.