Melina Rodriguez: FDA Approves Imaavy as First Treatment for Warm AIHA
Melina Rodriguez, Founder of Health Evidence Digest, Senior Medical Editor at Precision AQ, shared a post on LinkedIn:
“Imaavy (Nipocalimab) Receives FDA Approval as the First-Ever Treatment Proven Safe and Effective Specifically for Warm Autoimmune Hemolytic Anemia, Ending Decades of Off-Label Management With Non-Specific Immunosuppression.
On August 24, 2026, the FDA approved Imaavy (nipocalimab-aahu, Johnson and Johnson) as the first-ever treatment proven safe and effective for warm autoimmune hemolytic anemia.
Phase 2/3 ENERGY showed approximately 3x more patients achieved durable hemoglobin response versus placebo; mean hemoglobin improvement began at week 1.
Here is how FcRn blockade selectively reduces pathogenic IgG without broad immunosuppression and what the complete trial data shows….”
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