強生公司獲得 FDA 批准，Imaavy 用於治療温性自身免疫性溶血性貧血

強生公司獲得 FDA 批准，使用 Imaavy（nipocalimab-aahu）治療已使用皮質類固醇的 12 歲及以上成人和兒童的温熱性自身免疫性溶血性貧血。這是首個被證明對這種罕見疾病安全有效的療法，標誌着一個被忽視的患者羣體的重要里程碑

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)