FDA grants priority review for Genzyme’s Cerdelga

The US Food and Drug Administration has granted French drug major Sanofi (Euronext: SAN) and its subsidiary Genzyme a six-month Priority Review designation to its New Drug Application for Cerdelga (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1.

Cerdelga, a twice-daily capsule, provides an effective oral treatment alternative for patients with adult Gaucher disease type 1, as part of a broader range of treatment options for Gaucher patients and physicians. Genzyme’s clinical development program for eliglustat represents the largest clinical program ever conducted in Gaucher disease, with around 400 patients treated in 29 countries.

Genzyme’s president and chief executive David Meeker said: “The acceptance of our applications for Cerdelga represents another important milestone in our commitment to understand and respond to the needs in the Gaucher community, providing more choice for the treatment of patients.”