December 11, 2013

FDA Grants Priority Review for Genzyme’s CerdelgaTM (eliglustat), an Investigational Oral Therapy for Gaucher Disease

Second Major Regulatory Filing Following EMA Acceptance in Late October

 

FDA Grants Priority Review for Genzyme’s CerdelgaTM (eliglustat), an Investigational Oral Therapy for Gaucher Disease
Second Major Regulatory Filing Following EMA Acceptance in Late October

Paris, France – December 11, 2013 – Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for CerdelgaTM (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1. As previously announced, the European Medicines Agency in late October validated Genzyme’s marketing authorization application (MAA) for eliglustat in the EU.