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Novo Nordisk files NDA for diabetes drug in Japan

Novo Nordisk has submitted a new drug application to the Ministry of Health, Labour and Welfare in Japan for the approval of liraglutide, a once-daily human GLP-1 analogue, for the treatment of people with type 2 diabetes.

The Japanese Phase III program, which included 678 patients with type 2 diabetes, was designed to obtain the indication for use of liraglutide to treat type 2 diabetes as an adjunct to diet and exercise, both as monotherapy and in combination with sulfonylurea.

Liraglutide is a once-daily human analogue of the naturally occurring hormone Glucagon-Like Peptide-1 (GLP-1).

According to the company, liraglutide works by stimulating the release of insulin only when glucose levels become too high and by inhibiting appetite. In contrast to most other antidiabetic treatments, liraglutide also leads to weight loss instead of weight increase.