Imaavy Gets FDA Approval for Second Rare Blood Disorder Indication

Johnson & Johnson's (JNJ) therapy Imaavy has secured FDA approval for a second indication, targeting a rare and life-threatening blood condition known as warm autoimmune hemolytic anemia (wAIHA).

The treatment, also known as nipocalimab-aahu, works by blocking a protein that keeps harmful antibodies circulating in the bloodstream. The FDA granted approval following Priority Review for adults and pediatric patients aged 12 years and older who are currently or previously treated with corticosteroids.

Approval was based on data from the Phase 2/3 ENERGY trial, which showed that Imaavy-treated patients achieved a durable haemoglobin response compared to those on placebo. Approximately three times as many patients receiving the approved 30 mg/kg intravenous dose every four weeks achieved this response by Week 24.

Imaavy was originally approved in April 2025 for generalised myasthenia gravis, and its expanded label marks J&J's first such expansion. The company is now pursuing broader ambitions for the monoclonal antibody across a range of other indications, with Phase 3 trials underway in chronic inflammatory demyelinating polyneuropathy and Phase 2 trials in systemic lupus erythematosus and idiopathic inflammatory myopathy.