Sanofi Genzyme: COMET Phase 3 Trial - Results

Sanofi Genzyme: COMET Phase 3 Trial - Results

Posted On: 18/06/2020 Recently Posted!

In a press release dated 16th June 2020, Sanofi Genzyme presented results from their COMET phase 3 trial, designed to study the clinical and functional benefits of their second generation ERT, NeoGAA (Avalglucosidase alfa).

The results show a statistical non-inferiority to Myozyme (Lumizyme) in its primary endpoint (FVC), but failed to show statistical superiority. However, a range of secondary endpoints do seem to show increased strength across a range of muscle groups.

Sanofi will apply to the FDA for market approval in the second half of this year; it’s not yet clear if they will also submit an application to the European Medicine’s Agency (EMA).

On behalf of the global Pompe community, we would like to thank all patients who volunteered to take part in this and related studies.

To read the full press release, please follow this link:

https://www.sanofigenzyme.com/en/about-us/newsroom/2020/2020-06-16-12-00-00