Lift of clinical hold wrestles back ground for Zolgensma in SMA market
The US Food and Drug Administration (FDA) has recently lifted a clinical hold on the spinal muscular atrophy (SMA) drug OAV-101, an intrathecal (IT) formulation of Zolgensma (onasemnogene abeparvovec).
Swiss pharma giant Novartis (NOVN: VX) will now be able to begin a pivotal Phase III trial (STEER) to evaluate OAV-101 IT in treatment-naïve patients with SMA Type 2 aged between two and 18 years old, which, if successful, would greatly increase sales, says GlobalData, a data and analytics company.
Potential to more than double sales
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