5 Key Takeaways

• 1

  The FDA approved nipocalimab-aahu (IMAAVY) for adults and pediatric patients aged 12 and older with warm autoimmune hemolytic anemia.

• 2

  Nipocalimab is the first therapy specifically approved for warm autoimmune hemolytic anemia, previously approved for generalized myasthenia gravis.

• 3

  The approval was based on the phase 2/3 ENERGY trial, which involved 115 adults with wAIHA and compared nipocalimab to placebo.

• 4

  Participants receiving nipocalimab achieved a durable hemoglobin response approximately three times more than those on placebo by week 24.

• 5

  Common adverse reactions to nipocalimab included peripheral edema, diarrhea, and fever, with potential risks of infections and hypersensitivity.