Japanese authorities have licensed the use of Sanofi's new treatment for type 2 diabetes Lyxumia (lixisenatide).
The drug is a key part of Sanofi's diabetes portfolio and complements its basal insulin brand Lantus (insulin glargine), which brought in €5bn last year to make it the company's biggest selling product.
The green light by Japan's Ministry of Health, Labour and Welfare (MHLW) makes Sanofi's once-daily GLP-1 receptor agonist injection the first drug in its class to be approved for use with basal insulin.
Pierre Chancel, senior vice-president, global diabetes at Sanofi, said: "Lyxumia, as the first GLP-1 receptor agonist approved in Japan for use in combination with basal insulin, will be a valuable new treatment option for many of the country's 6 million plus people living with type 2 diabetes.
"The MHLW decision immediately enables the use of Lyxumia, which works in a way that complements basal insulin."
The company will be hoping this, and its efficacy results, will be enough to help it take on other GLP-1s already on the market, including Novo Nordisk's Victoza (liraglutide), which brought in more than €1.2bn last year.
Lyxumia is now licensed in Japan for patients with type 2 diabetes when diet and exercise and sulfonylureas (with and without biguanides) or diet and exercise and soluble prolonged-acting or intermediate-acting insulin (with and without sulfonylureas) do not provide adequate glycaemic control.
The MHLW's decision was based on Sanofi's GetGoal programme, which included a total of 11 clinical trials involving more than 5,000 patients with type 2 diabetes.
Among these trials is the pivotal phase III study GetGoal-L-Asia, whose 311 Asian patients included 159 from Japan.
A randomised, double-blind, placebo-controlled study with a 24-week treatment period, GetGoal-L-Asia assessed Lyxumia's safety and efficacy in patients who whose type 2 diabetes was insufficiently controlled with basal insulin with or without sulfonylurea.
It showed the drug, in combination with basal insulin (with or without sulfonylurea), significantly improved glyaemic control - with the addition of Lyxumia to basal insulin reducing A1C levels by 0.88 per cent versus placebo.