Sanofi’s Toujeo approved in Japan

pharmafile | July 3, 2015 | News story | Manufacturing and Production, Sales and Marketing |  Japan, Lantus Lantus XR, Sanofi, diabetes, toujeo, type diabetes 

The Ministry of Health, Labor and Welfare in Japan has given Sanofi a marketing authorisation for the diabetes drug the Swiss firm hopes will be the successor to its blockbuster Lantus.

Sanofi will market the new insulin glargine injection as Lantus XR in Japan, while it is known as Toujeo in the US and Europe, where it is already approved by the FDA, the EMA, and Health Canada.

Toujeo is a next-generation basal insulin for the treatment of type 1 and type 2 diabetes mellitus, where treatment with insulin is needed. Sanofi is pinning its hopes on Toujeo helping the French firm to fend off competition from Eli Lilly and Boehringer Ingelheim – who saw their Lantus biosimilar approved in the EU last year – and diabetes specialist Novo Nordisk – whose Tresbia (insulin degludec), a potential competitor to Toujeo, was recently resubmitted for FDA approval.

Pierre Chancel, who is senior vice president and head of global diabetes at Sanofi, says: “In just four months, Sanofi’s next generation basal insulin has been granted marketing authorisation by three major regulatory authorities. This first approval in Asia adds to the momentum of an active launch year, and it highlights our commitment to improving diabetes care worldwide.”

According to the national figures there are approximately 9.5 million people living with diabetes in Japan.

“For patients requiring basal insulin, Lantus XR could positively impact hypoglycaemia during the critical initiation phase, when most titration occurs, and beyond,” says Professor Masato Odawara of Tokyo Medical University.

“Japan-specific data show that Lantus XR patients experienced less nocturnal hypoglycaemia and no increase in hypoglycaemia at any time of the day – with glycaemic control comparable to Lantus.”

Toujeo is now available in the US, Germany, Denmark and the Netherlands and has been registered in Australia. Sanofi plans to launch it in other countries in the coming months.

Lilian Anekwe