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Muscular Dystrophy Association Calls FDA Approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a Major Step Forward for the Spinal Muscular Atrophy Community
The only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA). Muscular Dystrophy Association Calls FDA Approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a Major Step Forward for the Spinal Muscular Atrophy Community The Muscular Dystrophy Association calls FDA approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a major step forward for the spinal muscular atrophy community. New York, Nov. 24, 2025 (GLOBE NEWSWIRE)
About this update from Novartis Ag
[{"type":"text","content":"The only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA).","length":121,"tagName":"p"},{"type":"text","content":"Muscular Dystrophy Association Calls FDA Approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a Major Step Forward for the Spinal Muscular Atrophy Community","length":165,"tagName":"p"},{"type":"image","alt":"The Muscular Dystrophy Association calls FDA approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a major step forward for the spinal muscular atrophy community.","displaySize":"","headline":null,"caption":"The Muscular Dystrophy Association calls FDA approval of Novartis’ Itvisma (onasemnogene abeparvovec-brve) a major step forward for the spinal muscular atrophy community.","credit":"GlobeNewswire Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":397,"height":209,"url":"https://media.zenfs.com/en/globenewswire.com/62f1d6831b47b1e7d54f758fa8c7467a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/diiwRtTgR0iRZsziG9qxQw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM3MTtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/62f1d6831b47b1e7d54f758fa8c7467a","width":397,"height":209}}},{"type":"text","content":"New York, Nov. 24, 2025 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association (MDA) today called the U.S. Food and Drug Administration’s approval of Itvisma (onasemnogene abeparvovec-brve), developed by Novartis, a major step forward for families living with spinal muscular atrophy (SMA). The newly approved therapy is indicated for children two years and older, teens, and adults with a confirmed mutation in the SMN1 gene, making it the first and only gene replacement therapy available to this broader SMA population. Itvisma is an intrathecal formulation of Zolgensma — a gene therapy previously approved for infants with SMA — enabling gene replacement therapy to be delivered safely and effectively to older children, teens, and adults for the first time. This expanded treatment option provides renewed hope to people and families living with SMA. Read the Novartis press release here.","length":894,"tagName":"p"},{"type":"text","content":"The Muscular Dystrophy Association celebrates this important advancement for the spinal muscular atrophy (SMA) community we serve,” said Angela Lek, PhD, Chief Rese...