FDA grants Sanofi venglustat breakthrough therapy designation for Gaucher disease type 3

The US FDA granted Breakthrough Therapy designation to Sanofi’s oral investigational drug venglustat for neurological manifestations of Gaucher disease type 3. The designation was supported by Phase 3 LEAP2MONO data showing statistically significant improvement on a composite neurological score versus enzyme replacement therapy with imiglucerase (p=0.007). Sanofi said the most frequently reported adverse events included headache (14.3%) and nausea (14.3%).

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