Sanofi Says US FDA Grants Venglustat Breakthrough Therapy Designation for Type 3 Gaucher Disease
MT Newswires Live
Mar 18
Sanofi (SNY) said Wednesday the US Food and Drug Administration has granted breakthrough therapy designation for its investigational drug venglustat to treat neurological manifestations of type 3 Gaucher disease.
The company said the designation was based on results from a phase 3 study in which venglustat showed statistically significant improvements in neurological symptoms compared with enzyme replacement therapy imiglucerase.
The treatment was generally well tolerated, with no new safety signals observed, Sanofi said.
The company said it plans to pursue global regulatory filings for venglustat this year.
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