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Sanofi wins Japanese approval for diabetes drug Lyxumia

Becomes first treatment of its class licensed in combination with basal insulin

Sanofi reception 

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.

Lyxumia is now approved in Mexico, the European Union, Australia and Japan, and its US license application is currently under review.

1st July 2013

From: Sales



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