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Monday, December 30, 2024

Novartis Phase III study meets primary endpoint in spinal muscular atrophy

 

  • The Phase III STEER study met its primary endpoint showing an increase from baseline in HFMSE total score in patients with SMA treated with intrathecal onasemnogene abeparvovec (OAV101 IT)

  • OAV101 IT is the first investigational gene therapy to provide clinical benefit in treatment-naïve patients with SMA aged two and older with a positive risk benefit profile

  • Novartis plans to share results with regulatory agencies in 2025 with the aim to make OAV101 IT available to help patients with SMA in need


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