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May 29, 2026

FDA grants priority review for Sanofi’s venglustat NDA

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).

The LEAP2MONO Phase III trial evaluated venglustat’s efficacy and safety in adults and children aged 12 and above. Credit: Pickadook / Shutterstock.com.