Sanofi Wins FDA’s Approval For Pill to Treat Gaucher Disease

Sanofi won U.S. approval for a pill to treat Gaucher disease, an alternative to the company’s 20-year-old intravenous infusion Cerezyme.

The Food and Drug Administration cleared Cerdelga (eliglustat) for adults with Gaucher, a rare, inherited metabolic disorder that can cause fatigue and fragile bones. Sanofi’s existing drug, Cerezyme, replaces an enzyme missing in Gaucher patients while Cerdelga decreases the waste produced by cells that the missing enzyme is supposed to break down.

“Today’s approval offers another important treatment option for patients with Type 1 Gaucher disease,” Amy G. Egan, deputy director of the Office of Drug Evaluation III in FDA’s ...