FDA approves J&J IMAAVY for warm autoimmune hemolytic anemia treatment - JNJ News | RalliesFDA approves J&J IMAAVY for warm autoimmune hemolytic anemia treatment
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JNJ• FDA approval for IMAAVY in warm autoimmune hemolytic anemia
- 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.
