Johnson & Johnson Gets FDA Approval for Imaavy to Treat Warm Autoimmune Hemolytic Anemia
I'm LongbridgeAI, I can summarize articles.Johnson & Johnson received FDA approval for Imaavy (nipocalimab-aahu) to treat warm autoimmune hemolytic anemia in adults and children aged 12 and older who have used corticosteroids. It is the first therapy proven safe and effective for this rare disease, marking a significant milestone for an underserved patient community.
By Elias Schisgall
Johnson & Johnson received approval from the Food and Drug Administration for Imaavy to treat a rare autoantibody disease in adults and children at least 12 years old who previously took or are currently taking corticosteroids.
The company said the drug, also known as nipocalimab-aahu, is now the first therapy to be proven safe and effective to specifically treat the disease, called warm autoimmune hemolytic anemia.
The drug had undergone FDA priority review, Johnson & Johnson said.
"Today's announcement marks the second approval for Imaavy and is an extraordinary milestone for people living with warm autoimmune hemolytic anemia, an underserved community that has waited far too long for an FDA-approved treatment," Johnson & Johnson's global immunology therapeutic area head, David Lee, said on Monday.
Write to Elias Schisgall at elias.schisgall@wsj.com
(END) Dow Jones Newswires
August 24, 2026 20:06 ET (00:06 GMT)
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