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US panel review likely to delay Novo Nordisk's liraglutide

This article was originally published in Scrip

Executive Summary

Novo Nordisksaid the US FDAwill hold an advisory panel review on March 2nd of the company's NDA for the GLP-1 analogue liraglutide in type 2 diabetes. Since the 10-month review deadline for liraglutide is March 23rd, the FDA will likely extend the review period by a couple of months, Novo Nordisk said. The company filed the once-daily injectable therapy in May for use as monotherapy and in combination with other diabetes medicines. A key focus of the FDA panel's discussion is likely to be the drug's cardiovascular effects. In July the endocrinologic and metabolic drugs advisory panel said all drugs in development for type 2 diabetes should undergo long-term safety trials to rule out an excessive CV risk (Scrip Online, July 3rd, 2008). Lilly/Amylin's similar incretin mimetic Byetta (exenetide) has also been the subject of safety concerns over pancreatitis, raising questions over whether this could be a class effect (Scrip Online, August 27th, 2008).

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