Novartis Itvisma wins positive EU CHMP opinion for spinal muscular atrophy
PUBT · 3d ago
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- EMA CHMP issued positive opinion recommending EU marketing authorization for Novartis Itvisma (intrathecal onasemnogene abeparvovec) to treat 5q spinal muscular atrophy in patients aged 2 years and older.
- Novartis expects European Commission final decision within about two months.
- Phase III STEER study showed 2.39-point HFMSE improvement on Itvisma vs 0.51 on sham (p=0.0074).
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Novartis AG published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202604240630OMX_____CNEWS_EN_GNW1001177798_en) on April 24, 2026, and is solely responsible for the information contained therein.
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