Sanofi announced that its New Drug Application (NDA) for its investigational basal insulin Toujeo was accepted for review by the U.S. Food and Drug Administration (FDA).
Toujeo is the brand name for insulin glargine [rDNA origin] injection, 300 U/mL, formerly known as U300. The NDA application for Toujeo was supported by results from the EDITION trial program comprising Phase 3 studies investigating the drug’s safety and efficacy in more than 3,500 patients. Analysis of three late stage trials in patients with Type 2 diabetes showed that the drug decreased the risk of low blood sugar events of up to 31 percent at night compared against Lantus — Sanofi’s top diabetes drug which holds the distinction of being the most prescribed insulin in the world. The drug, however, is nearing the edge of its patent cliff in February next year.
Diabetes remains a highly prevalent disease with 347 million people affected across the world. The World Health Organization predicts that the disease will be the 7th leading cause of death in 2030. Type 2 diabetes accounts for 90 percent of diabetes cases worldwide and is mainly attributed to obesity and physical inactivity. Once known as adult-onset diabetes, T2D is now also increasingly seen in children.
Commenting on the acceptance of the company’s U.S. application, Pierre Chancel, SVP of Global Diabetes at Sanofi, said, “By reaching this key milestone in the approval process, we are pleased to take another step forward with Toujeo, an investigational new basal insulin that has been evaluated in a broad range of people living with diabetes. With the FDA’s acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the U.S. in the first half of 2015.”
The FDA acceptance of Sanofi’s NDA for Toujeo comes after the acceptance of the company’s marketing authorization dossier by the European Medicines Agency (EMA) in May.