Approved for manufacturing and distribution, Lyxumia is a first once-daily prandial GLP-1 receptor agonist (RA) offering a new treatment option for the people living in the region with type 2 diabetes.
Lyxumia targets post-prandial glucose that is believed to be an effective strategy to further lower blood glucose levels and reach HbA1c goals.
The combination therapy is indicated in case 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 glycemic control.
Sanofi global diabetes senior vice-president Pierre Chancel 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."
MHLW approval is based on the data from the international GetGoal program in which a total of 11 clinical trials with over 5,000 type 2 diabetes patients were involved.
The NDA for lixisenatide in the US is currently being reviewed, while it is already approved in Mexico, the European Union, Australia and Japan.