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Type 2 Drugs: EU Approves “Victoza,” FDA Extends Review of “Onglyza”

May 6, 2009

The FDA had originally intended to complete its review by April 30. Although a majority of the agency’s Endocrinologic and Metabolic Drugs Advisory Committee believes that saxagliptin does not present an “unacceptable” risk of creating cardiovascular problems in normal type 2 users, they want additional time to study the drug’s effects among type 2 patients who are already at a higher risk of cardiovascular problems.

The European Union's drug regulation agency has recommended that the EU approve the marketing of "Victoza" (liraglutide), a type 2 drug developed by Novo Nordisk.

The recommendation by the European Medicines Agency, based in London, could mean that the drug will reach the European market by late July.

At the same time, the U.S. Food and Drug Administration has announced that it wants 90 more days to review Onglyza (saxagliptin), a type 2 diabetes drug developed by AstraZeneca PLC and Bristol-Meyers Squibb Co.

The FDA had originally intended to complete its review by April 30. Although a majority of the agency's Endocrinologic and Metabolic Drugs Advisory Committee believes that saxagliptin does not present an "unacceptable" risk of creating cardiovascular problems in normal type 2 users, they want additional time to study the drug's effects among type 2 patients who are already at a higher risk of cardiovascular problems.

Liraglutide is in the same class as Byetta (exenatide), a long-acting glucagon-like peptide-1 analog. Like Byetta, the drug reduces blood glucose levels by increasing insulin secretion, slowing gastric emptying, and suppressing mealtime secretion of glucagon. secretion. It is intended to be taken as a once-daily drug.

Saxagliptin is a dipeptidyl peptidase-4 inhibitor, an oral glucose-lowering drug that works much the same as exenatide.

Categories: Blood Glucose, Byetta, Diabetes, Diabetes, Food, Heart Care & Heart Disease, Insulin, Medications Research, Novo Nordisk, Onglyza, Type 2 Issues, Type 2 Medications, Victoza

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Type 2 Drugs: EU Approves “Victoza,” FDA Extends Review of “Onglyza”

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