Sanofi has won European approval for its new long-acting insulin Toujeo as a treatment for adults with type 1 and 2 diabetes.
Toujeo (insulin glargine [rDNA origin[injection, 300 U/mL) is the company’s follow-up product to its €6.3bn a year blockbuster Lantus (insulin glargine) and a key part of the company’s growth plans.
Pierre Chancel, senior vice-president of global diabetes at Sanofi, said: “The EU marketing authorisation for Toujeo represents a significant milestone for Sanofi, expanding our integrated portfolio of solutions for people with diabetes in Europe.”
Toujeo’s marketing authorisation from the European Commission came on the back of the EDITION clinical trial programme. Its package of phase III trials compared Toujeo to Lantus and found Toujeo to have comparable glycaemic control, a lower rate of hypoglycaemia in patients with type 2 diabetes and a similar incidence of hypoglycaemia in type 1 diabetes patients.
The biologic’s European approval comes almost exactly two months after US regulator the FDA gave it the green light and less than one month after the French pharma company’s new chief executive Olivier Brandicort took the helm.
Given the importance of Lantus to Sanofi – last year it accounted for 18% of the company’s entire sales – and the looming threat of biosimilar competition from Lilly/Boehringer, Toujeo’s performance will be one of Brandicort’s first major tests.
However, the company will have slightly longer to establish Toujeo than it originally expected after regulatory filings for Lilly’s insulin peglispro were delayed recently due to safety concerns.