November Date Set for FDA Decision on Sanofi's Gaucher Drug

November date set for FDA decision on Sanofi's Gaucher drug

The FDA has started a priority review of Sanofi's brain-acting Gaucher disease therapy venglustat, with an action date of 25th November.

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.

FDA Grants Priority Review to Sanofi’s Investigational Oral Therapy Venglustat for Type 3 Gaucher Disease

Open the article to view the coverage from EuropaWire.eu

Press Release: Sanofis venglustat accepted for priority review in the US to treat type 3 Gaucher disease

Sanofi’s venglustat accepted for priority review in the US to treat type 3 Gaucher disease Paris, May 28, 2026. The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), […] The post Press Release: Sanofis venglustat accepted for priority review in the US to tre…