Shots:
- The US FDA has granted BTD to venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3)
- Designation was based on the P-III (LEAP2MONO) study assessing venglustat (QD, PO) vs imiglucerase (Q2W) in 43 pts (≥12yrs.), which showed significant improvements in neurological symptoms measured by a global test scores, incl. mSARA & RBANS
- Venglustat received US FDA fast-track designation & orphan status in the US, EU & Japan for GD3. Also, Sanofi is planning to pursue global regulatory filings for venglustat in GD3 during 2026
Ref: Globenewswire | Image: Sanofi |Press Release
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