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BioWorld - Thursday, December 11, 2025
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Home » Novartis’ Itvisma wins US FDA approval for SMA patients ages 2+
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Novartis’ Itvisma wins US FDA approval for SMA patients ages 2+

Nov. 25, 2025
By Karen Carey
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More than six years after Novartis AG’s Zolgensma was approved for children under 2 with spinal muscular atrophy (SMA) with biallelic mutations in the survival motor neuron 1 gene, the U.S. FDA cleared a new version, under the brand name Itvisma (onasemnogene abeparvovec), for those 2 and older, including teens and adults with the same mutation.
BioWorld Regulatory Musculoskeletal Gene therapy U.S. FDA

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