Sanofi’s venglustat accepted for priority review by FDA

The US Food and Drug Administration (FDA) has granted priority review to the new drug application (NDA) for Sanofi’s (Euronext: SAN) venglustat, a novel, investigational oral glucosylceramide synthase inhibitor (GCSi), for the treatment of type 3 Gaucher disease (GD3), a rare lysosomal storage disorder.

The French pharma major noted that, if approved, venglustat would become the first treatment available in the USA to address the progressive neurological manifestations associated with GD3 and expand Sanofi’s portfolio of treatment options for patients living with lysosomal storage diseases. The target action date for the FDA decision is November 25, 2026.