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FDA Grants Priority Review for Cerdelga (Eliglustat)
2013-12-16 20:12:31

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

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Genzyme, a Sanofi company announced today that the Food and Drug Administration (FDA) has granted a six-month Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (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.