The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune haemolytic anaemia (wAIHA) – a rare, life-threatening autoantibody disease – in adults and paediatric patients 12 years of age and older currently or previously treated with corticosteroids.
The approval, which follows FDA Priority Review, marks the first time a therapy was proven safe and effective specifically for the treatment of wAIHA.
The primary endpoint of the phase 2/3 study was durable haemoglobin (Hgb) response, a stringent endpoint definition that reflects meaningful increases in Hgb levels over time.
