FDAnews Drug Daily Bulletin
Pharmaceuticals / Submissions and Approvals

Sanofi Genzyme Gains Health Canada Approval for Cerdelga

May 10, 2017

Ontario–based Sanofi Genzyme, a division of Sanofi-Aventis Canada, has gained Health Canada’s approval of Cerdelga (eliglustat capsules), an oral therapy indicated for the treatment of adult patients with Gaucher disease type 1.

Gaucher disease is a genetic metabolic condition caused by deficient activity of the enzyme glucocerebrosidase which breaks down waste material within cells.

In clinical studies in untreated patients with Gaucher disease type 1, Cerdelga produced improvements in platelet and hemoglobin levels, spleen and liver volumes and bone outcomes. In patients whose disease had been stabilized with ERT, Cerdelga maintained stability of the disease parameters.

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