我是 LongbridgeAI，我可以总结文章信息。强生公司获得 FDA 批准，使用 Imaavy（nipocalimab-aahu）治疗已使用皮质类固醇的 12 岁及以上成人和儿童的温热性自身免疫性溶血性贫血。这是首个被证明对这种罕见疾病安全有效的疗法，标志着一个被忽视的患者群体的重要里程碑
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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