FDA grants priority review for Sanofi’s venglustat NDA

Sanofi has received a priority review from the FDA for its NDA for venglustat, an oral GCSi intended for the treatment of type 3 GD3. 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…

Source: Pharmaceutical Technology