CHMP grants positive opinion to Sanofi/Genzyme's Cerdelga in Gaucher disease

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion on French drug major Sanofi’s (Euronext: SAN) and its subsidiary Genzyme’s Cerdelga (eliglustat) in adults with Gaucher disease type 1.

The European Commission will make a final decision on granting marketing authorization for Cerdelga in the EU in the coming months, and the drug has already been approved by the US Food and Drug Administration. It is under review by regulatory authorities around the world.

David Meeker, Genzyme president and chief executive, said: "Today's CHMP opinion is the next step in ensuring that Cerdelga is available to eligible adults with Gaucher disease type 1 living in the European Union. The standard of care for Gaucher disease is Cerezyme (imiglucerase for injection). With the availability of an effective oral therapy, Cerdelga would offer patients and their physicians more choice in how to manage this serious disease."