US healthcare company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Monday that the US Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for IMAAVY (nipocalimab-aahu), for treatment of warm autoimmune haemolytic anomia (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.

According to J&J, IMAAVY is the first therapy to receive FDA Priority Review for this condition. It 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 utilises a differentiated immunoselective 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. Full results of the ENERGY trial will be presented at an upcoming medical conference.