Ionis publishes ZANVASTRO FDA approval presentation for Alexander disease treatment

Ionis published slides outlining FDA clearance of ZANVASTRO (zilganersen) for pediatric and adult Alexander disease patients.

• Material launch catalyst for Ionis’ first independently commercialized neurology medicine in the U.S.
• Pivotal trial met its primary endpoint in patients aged 5 or older, stabilizing 10-meter walk test gait speed at Week 61 (p=0.041).
• Secondary measures supported efficacy, including GMFM-88 improvement in ages 2-4 (nominal p=0.034) plus plasma GFAP reduction (nominal p=0.003).
• Safety profile described as generally mild-to-moderate; one aseptic meningitis serious event resolved without discontinuation.