Sanofi Granted FDA Priority Review for Potential Treatment of Rare Gaucher Disease

MT Newswires Live05-28

Sanofi (SNY) has been granted US Food and Drug Administration priority review for a new drug application for venglustat for the treatment of type 3 Gaucher disease, a rare disorder, the company said Thursday.

The application is backed by data from a phase 3 study in which venglustat met both its primary endpoints and three out of four key secondary endpoints, the drugmaker said.

The target action date for the FDA decision is November 25, the company said.

Gaucher disease results in an abnormal buildup of sugar-and-fat molecules in the spleen, liver, bone marrow, and lungs, potentially causing neurological and cognitive challenges.

Sanofi will pursue more global regulatory filings for venglustat this year, it said.

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