Sanofi's NDA for basal insulin Toujeo accepted by FDA

The US Food and Drug Administration has accepted for review French pharma major Sanofi’s (Euronext: SAN) New Drug Application for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL), an investigational basal insulin, the company announced this morning.

This follows the recent acceptance of the marketing authorization dossier for Toujeo (formerly dubbed U300) by the European Medicines Agency for European Union countries on May 27 this year. The drug is Sanofi’s successor to its blockbuster brand Lantus (insulin glargine), which is due to lose patent exclusivity in the USA in February 2015, and generated sales of 5.72 billion euros ($7.77 billion) for the company last year. Sanofi’s shares edged 0.5% higher to 77.24 euros in early trading this morning.

Approval decision anticipated in first-half 2015

"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," said Pierre Chancel, senior vice president, Global Diabetes at Sanofi. "With the FDA's acceptance of our submission, we are anticipating the regulatory decision for marketing authorization for Toujeo in the USA in the first half of 2015," he added.