FDA approves J&J IMAAVY for warm autoimmune hemolytic anemia treatment

PUBT · 2d ago
FDA approves J&J IMAAVY for warm autoimmune hemolytic anemia treatment
  • FDA cleared IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia in patients aged 12+ who are current or prior corticosteroid users.
  • Decision makes IMAAVY the first treatment specifically proven safe and effective for wAIHA, based on the Phase 2/3 ENERGY trial.
  • Trial data showed a mean hemoglobin increase of 1 g/dL at Week 1, with improved FACIT-Fatigue scores at Week 24.


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