Shots:
- FDA has approved Zanvastro (50mg, Q3M, intrathecal injection) for the treatment of AxD in pediatric & adult pts, with launch expected in the coming wks. FDA also granted Ionis a Rare Pediatric Disease PRV
- Approval was backed by the Phase I-III trial assessing Zanvastro (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.) for 60wks., followed by an open-label period & 120wk. open-label LTE, where 25mg cohort moved to the 50mg
- Trial showed zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus showed improvement in gross motor function in pts(2-4yrs.) as assessed by GMFM-88. Benefit in key secondary & exploratory EPs was also observed
Ref: Businesswire | Image: Ionis | Press Release
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