Sanofi, a global and diversified healthcare leader, has submitted the marketing authorization application for Lyxumia (lixisenatide), an investigational once-daily GLP-1 receptor agonist to the Ministry of Health, Labour and Welfare in Japan.

The application is supported by data from the extensive international GetGoal phase III clinical trial programme, which has assessed lixisenatide’s intended indication for the treatment of adults with type 2 diabetes with the aim of achieving glycemic control in patients who were not adequately controlled on diet and exercise with or without oral anti-diabetics and/or basal insulin. The GetGoal programme has enrolled more than 5,000 participants, including subjects in Japan, and has studied the highest numbers of patients to evaluate a GLP-1 in combination with basal insulin.

The GetGoal programme has established lixisenatide’s good efficacy and safety profile, demonstrating a significant reduction in HbA1c. As expected from a GLP-1 receptor agonist, lixisenatide was associated with a low risk of hypoglycemia, and in terms of tolerability, nausea and vomiting were the most commonly reported adverse events. Data for the regulatory submission includes positive results from the GetGoal-L Asia study investigating the efficacy and safety of lixisenatide versus placebo in Asian patients with type 2 diabetes who were insufficiently controlled on basal insulin ± sulfonylurea on top of diet and exercise.

The submission to the Ministry of Health, Labour and Welfare follows the acknowledged receipt of the market authorization application filing for lixisenatide by the European Medicine Agency (EMA) in November 2011. Submission for regulatory approval of lixisenatide in the United States is expected in Q4 2012.The first set of results from the various studies of the GetGoal programme have been published in peer reviewed medical journals, and others will be submitted for publication in the next few months.

Lixisenatide, a glucagon-like peptide-1 agonist (GLP-1), is in development for the treatment of patients with type 2 diabetes mellitus. Lixisenatide was in-licensed from Zealand Pharma A/S (Copenhagen, Denmark), www.zealandpharma.com. Lyxumia is the intended trademark of lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.

GLP-1 is a naturally-occurring peptide that is released within minutes of eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate insulin secretion by pancreatic beta cells. GLP-1 receptor agonists are in development as an add-on treatment for type 2 diabetes and their use is endorsed by the European Association for the Study of Diabetes, the American Diabetes Association, the American Association of Clinical Endocrinologists and the American College of Endocrinology.

The GetGoal phase III clinical programme provides data for lixisenatide in adults with type 2 diabetes treated in monotherapy, with various oral anti-diabetic agents or in combination with basal insulin. The GetGoal programme started in May 2008 and has enrolled more than 5,000 participants.

Sanofi strives to help people manage the complex challenge of diabetes by delivering innovative, integrated and personalized solutions. It markets both injectable and oral medications for people with type 1 or type 2 diabetes. Investigational compounds in the pipeline include an injectable GLP-1 agonist being studied as a single agent, in combination with basal insulin, and/or in combination with oral anti-diabetic agents.