New option for Japanese with type 2 diabetes

PARIS – Sanofi (EURONEXT : SAN and NYSE : SNY) said that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved the manufacturing and distribution of Lyxumia^? (lixisenatide) for the treatment of type 2 diabetes. The glucagon-like peptide-1 receptor agonist (GLP-1 RA) 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 theuse 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 HbA _1c 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 HbA _1c 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 was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), 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.

1 Aronoff et al. Glucose metabolism and regulation: Beyond insulin and glucagon.New Balance