Shots:
- The US FDA has granted BTD to zilganersen for the treatment of Alexander disease (AxD)
- Designation was supported by the topline P-III trial data, which assessed zilganersen (25 or 50mg) vs control in 54 AxD pts (1.5-53yrs.). Zilganersen (50mg) met the 1EP of gait speed as assessed by 10-Meter Walk Test at 61wks., plus showed consistent benefit in key 2Eps
- Additionally, Ionis is planning to submit an NDA for zilganersen to the FDA in Q1’26 & to initiate an EAP in the US
Ref: Ionis | Image: Ionis | Press Release
Related News: The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)
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