FDA approves first therapy for warm autoimmune hemolytic anemia

The phase 2/3 ENERGY trial evaluated durable hemoglobin response with nipocalimab vs placebo in adults with warm autoimmune hemolytic anemia.

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The FDA approved nipocalimab-aahu (IMAAVY) for adults and pediatric patients aged 12 and older with warm autoimmune hemolytic anemia.
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Nipocalimab is the first therapy specifically approved for warm autoimmune hemolytic anemia, previously approved for generalized myasthenia gravis.
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The approval was based on the phase 2/3 ENERGY trial, which involved 115 adults with wAIHA and compared nipocalimab to placebo.
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Participants receiving nipocalimab achieved a durable hemoglobin response approximately three times more than those on placebo by week 24.
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Common adverse reactions to nipocalimab included peripheral edema, diarrhea, and fever, with potential risks of infections and hypersensitivity.

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