PARIS (dpa-AFX) - Sanofi SA (SNY) on Thursday said the US Food and Drug Administration (FDA) has granted priority review to the new drug application for venglustat for the treatment of type 3 Gaucher disease, a rare lysosomal storage disorder.
A decision form the regulator is expected on November 25, 2026.
If approved, venglustat would become the first treatment available in the U.S. to address the progressive neurological manifestations associated with GD3, Sanofi added.
The application is backed by positive data from the Phase 3 LEAP2MONO study, which evaluated the efficacy and safety of venglustat in adult and pediatric patients with neurological manifestations of GD3 whose systemic symptoms had previously stabilized with enzyme replacement therapy.
Venglustat is also under review in the European Union, with additional global regulatory filings planned in 2026.
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