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12:00 AM
 | 
Oct 25, 2010
 |  BioCentury  |  Regulation

Victoza's QT difference

Victoza's lack of renal excretion lowered QT hurdle for Novo Nordisk in diabetes

Unlike Amylin Pharmaceuticals Inc. and Eli Lilly and Co., Novo Nordisk A/S did a thorough QT study of its GLP-1 receptor agonist prior to seeking U.S. approval to treat Type II diabetes. And Novo did not need to test supratherapeutic doses of its Victoza liraglutide, which FDA has asked Amylin and Lilly to perform as part of the agency's complete response letter last week for Bydureon once-weekly exenatide.

The reason for the difference is that Victoza is not renally excreted, so that plasma concentrations of the drug do not become elevated in patients with Type II diabetes and renal insufficiency. Exenatide is excreted through the kidneys.

According to its label, Victoza is "endogenously metabolized in a similar manner to large proteins without a specific organ as a major route of elimination."

Victoza has a C16 free fatty acid attached to the GLP-1 molecule, allowing it to noncovalently bind to albumin. The result is...

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