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

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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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