EU Approves Sales of Sanofi’s New Diabetes Drug
The European Commission has granted marketing authorization in Europe for Sanofi's Toujeo, a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus in adults.
The Commission said its decision was based on results from the Edition clinical trial program, a series of worldwide Phase III studies evaluating the efficacy and safety of Toujeo compared with Lantus, another Sanofi product, in more than 3,500 adults with type 1 or type 2 diabetes.
Pierre Chancel, senior vice president, Global Diabetes, at Sanofi, said EU marketing authorization for Toujeo represents a "significant milestone" for the company, expanding its integrated portfolio of solutions for people with diabetes in Europe."
The marketing approval follows the Feb. 26 positive opinion issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
Toujeo also has been approved by the US Food and Drug Administration (FDA) and is under review by regulatory authorities in other countries.
