Japan’s Ministry of Health, Labor and Welfare (MHLW) approved the manufacturing and distribution of Sanofi’s new type 2 diabetes treatment, Lyxumia (lixisenatide) in Japan.
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 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).
MHLW approval in Japan of Lyxumia 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.
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.
