Market Overview

FDA Grants Priority Review for Genzyme's Cerdelga for Gaucher Disease


a Sanofi company (NYSE: SNY), 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.

Genzyme is developing eliglustat, a capsule to be taken twice daily, to
provide an effective oral treatment alternative for adult patients with
Gaucher disease type 1, and to provide a broader range of treatment
options for Gaucher patients and physicians. Genzyme's clinical

See full press release

Posted-In: News Guidance Contracts FDA Management Global


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