The decision is anticipated by 25 November 2026.
The LEAP2MONO Phase III trial evaluated venglustat’s efficacy and safety in adults and children aged 12 and above. Credit: Pickadook / Shutterstock.com.
Sanofi has received a priority review from the US Food and Drug Administration (FDA) for its new drug application (NDA) for venglustat, an oral glucosylceramide synthase inhibitor (GCSi) intended for the treatment of type 3 Gaucher disease (GD3).
If approved, venglustat would be the first treatment in the US to address the neurological symptoms of GD3, which currently have no targeted therapies. The decision is anticipated by 25 November 2026. Discover B2B Marketing That Performs
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