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Novartis wins EU approval for Itvisma gene therapy in older SMA patients

2. Jul 2026

(AWP Alliance News) - Novartis won European Commission clearance for Itvisma for 5q spinal muscular atrophy in patients aged 2 and older, including teens and adults, with bi-allelic SMN1 mutations. It is the first gene replacement therapy authorized in the EU for this broader older-patient group.

The one-time fixed-dose treatment is designed to replace the faulty SMN1 gene.

https://www.globenewswire.com/NewsRoom/ReleaseNg/402437681

Disclaimer: This news brief was created using generative artificial intelligence. Novartis AG published the original content used to generate this news brief via GlobeNewswire on July 02, 2026, and is solely responsible for the information contained therein.

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