赛诺菲糖尿病药物Lyxumia获日本MHLW批准

赛诺菲（Sanofi）6月28日宣布，Lyxumia（lixisenatide）获日本卫生劳动福利部（MHLW）批准用于2型糖尿病的治疗。

Lyxumia是首个日服一次的餐时(prandial) GLP-1受体激动剂（RA），同时也是日本首个获批与基础胰岛素联合用药的GLP-1 RA。

Lyxumia适用于锻炼+饮食+磺脲类药物或锻炼+饮食+可溶性长效或中效胰岛素（有或无磺脲类药物）无法充分控制血糖水平的2型糖尿病患者。

目前，Lyxumia已获墨西哥、欧盟、澳大利亚、日本批准。在美国，该药的新药申请（NDA）正接受FDA的审查。

英文原文：Lyxumia (R) is First Diabetes Therapy of its Class Approved in Japan for use in Combination with Basal Insulin

Friday, Jun 28, 2013, 18:10 IST | Agency: PR Newswire

Sanofi (EURONEXT : SAN and NYSE : SNY) announced today that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the manufacturing and distribution of Lyxumia(R) (lixisenatide) for the treatment of type 2 diabetes. Lyxumia, the first once-daily prandial GLP-1 receptor agonist (RA), is also the first GLP-1 RA approved in Japan for use in combination with basal insulin. Lyxumia is indicated for patients with type 2 diabetes mellitus when the following do not provide adequate glycemic control: 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).

"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," said Pierre Chancel, Senior Vice-President, Global Diabetes at Sanofi. "The MHLW decision immediately enables the use of Lyxumia, which works in a way that complements basal insulin."

Although basal insulin treatment provides effective control of overall glucose excursions by primarily targeting fasting plasma glucose (FPG),[1],[2] as diabetes progresses over time, patients treated with basal insulin may no longer stay at their HbA1c goals, despite good control of FPG. When this happens, adding a medicine such as Lyxumia, which targets post-prandial glucose, may be an effective strategy to further lower blood glucose levels and reach HbA1c goals.

MHLW approval in Japan is supported by the international GetGoal program, 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, which included 159 patients from Japan.[3]

Lyxumia is now approved in Mexico, the European Union, Australia and Japan. The New Drug Application for lixisenatide in the United States is currently being reviewed.

About Lyxumia(R) (lixisenatide)

Lyxumia(R) (lixisenatide) is a glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of patients with type 2 diabetes mellitus. GLP-1 is a naturally-occurring peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells.

Lyxumia was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), http://www.zealandpharma.com, and is approved in Europe for the treatment of adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together with diet and exercise, do not provide adequate glycemic control. Lyxumia is also approved in Mexico and Australia for the treatment of adults with type 2 diabetes. Lyxumia is the proprietary name approved by the European Medicines Agency and other health authorities for the GLP-1 RA lixisenatide. The proprietary name for lixisenatide in the United States is under consideration.