Sanofi announced late Wednesday that it received approval from the U.S. Food and Drug Administration (FDA) to sell its new insulin product Toujeo. The once-daily, long-acting basal insulin will help improve glycemic control in adults with type 1 and type 2 diabetes.
Toujeo, the successor to Sanofi’s flagship insulin Lantus, is a crucial launch for the drug maker. Sanofi is depending on Toujeo to help offset sales when its top-selling insulin Lantus loses U.S. patent protection, expected later this year.
Sanofi is looking to heavily market Toujeo to sustain its position in the competitive diabetes market—a challenge for the drug maker’s new chief executive, Olivier Brandicourt, who is scheduled to take over in April.
Diabetes generates more than $38 billion in yearly sales, according to a study by EvaluatePharma. In 2013, Sanofi was the second biggest seller in the market, behind Novo Nordisk A/S, primarily because of its Lantus sales.
“Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade,” said Sanofi Global Diabetes SVP Pierre Chancel in a statement. “With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes.”
The FDA based its approval of Toujeo on a review of results from the EDITION clinical trial program, which was made up of a series of international Phase 3 studies that evaluated the efficacy and safety of the insulin drug in more than 3,500 adults with type 1 and type 2 diabetes. Toujeo was compared to Lantus, and all studies of the program successfully met the primary study endpoints by demonstrating similar blood sugar control.
Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) is expected to be available in the U.S. at the beginning of the second quarter. The insulin drug is currently pending marketing authorization with the European Medicine Agency (EMA).
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Filed Under: Drug Discovery