Novo Nordisk Seeks U.S. and European Approval for Type 2 Drug Liraglutide

Hans Christian Hagedorn (1888-1971) and August Krogh founded Nordisk Insulin Laboratorium in 1923

Jun 19, 2008

Drug manufacturer Novo Nordisk has applied to the U.S. Federal Drug Administration and the European Medicines Agency for approval of liraglutide, a human GLP-1 analog* that is taken once daily for the treatment of type 2 diabetes.

The company’s applications are based on a study of 6,500 type 2s, 4,200 of whom received liraglutide as a diet and exercise adjunct. Some of the drug’s recipients used it in combination with other medications used to treat diabetes, while others received it as a monotherapy.

Researchers compared the effects of liraglutide with three other common anti-diabetic drugs: sulfonylureas (such as glipizide); glitazones (such as Actos and Avandia); and basal insulin.

Study participants initially averaged A1c levels of just under 8.5% and body weights of 175 to 200 pounds. At the end of liraglutide’s Phase III trial, 40 percent of participants had reached the ADA goal A1c of 7%. They also enjoyed a weight loss of 4.5 to 9 pounds.

The reductions in A1c percentages and weight were not unexpected—liraglutide is analogous to exenatide, whose commercial version, Byetta, has been a spectacularly successful type 2 treatment extolled for its glucose control and weight loss properties. (The FDA is now considering whether Byetta can qualify as a monotherapy.)

By late September, 2008, Novo Nordisk plans to file for approval to market liraglutide in Japan.

*GLP-1 (“glucagon-like peptide”) is an incretin hormone that stimulates the release of insulin from pancreatic beta cells.

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Categories: A1c Test, Diabetes, Diabetes, Endocrinology, Insulin, Medications, Novo Nordisk, Type 2 Issues, Type 2 Medications

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Jun 19, 2008

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