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FDA grants Priority Review to IMAAVY for treating rare, life-threatening warm autoimmune hemolytic anemia

Market News
27 Apr 2026
PRNewsWire
View Source
Bullish
pluang ai news

The FDA has granted Priority Review to Johnson & Johnson's IMAAVY (nipocalimab) for warm autoimmune hemolytic anemia (wAIHA), a rare and serious disease where autoantibodies destroy red blood cells causing severe anemia. IMAAVY targets the disease's root cause by reducing harmful immunoglobulin G antibodies while preserving immune function. This designation highlights the urgent need for effective treatments, as current therapies are limited and unapproved for wAIHA. The FDA review is expected to take about six months, supported by positive Phase 2/3 trial results showing improved hemoglobin levels and reduced fatigue in patients.

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