Johnson & Johnson has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY (nipocalimab-aahu), confirming the urgent need for treatment options in warm autoimmune haemolytic anaemia (wAIHA).
Priority Review is granted to medicines that may offer significant improvements in safety or effectiveness for serious conditions and shortens the FDA review timeline to approximately six months. IMAAVY is the first therapy to receive FDA Priority Review for this condition.
“Warm autoimmune haemolytic anaemia is a severe disease in which pathogenic immunoglobulin G (IgG) antibodies, also called autoantibodies, drive destruction of red blood cells. Currently, patients depend on broad immunosuppressive therapies that fail to address the underlying cause of disease and are not approved as safe or effective to treat wAIHA,” said Leonard L. Dragone, disease area leader, autoantibody and rheumatology, Johnson & Johnson.
“This designation highlights both the serious, life-threatening nature of wAIHA and the potential for IMAAVY, if approved, to help address a critical unmet need by delivering clinically meaningful outcomes for patients.”
IMAAVY is designed to block the neonatal Fc receptor (FcRn), reducing circulating IgG, including pathogenic autoantibodies, while preserving key immune functions. By targeting the underlying driver of disease, IMAAVY utilizes a differentiated immune-selective approach in a condition where many patients currently rely on therapies that are unapproved for wAIHA, including corticosteroids and broad immunosuppressants.
The FDA’s decision to grant Priority Review is supported by results from the pivotal phase 2/3 ENERGY study, which showed that more patients treated with IMAAVY achieved a durable haemoglobin response compared with placebo, along with improvements in fatigue, a critical outcome for people living with wAIHA. The full results of the ENERGY trial will be presented at an upcoming medical conference.
Nipocalimab is being studied across multiple auto- and alloantibody-driven diseases.