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Novo Readies For Victoza CV Benefit Claim With US FDA Panel Nod

 
• By Sue Sutter

HeartofType2 unbranded campaign is aimed at increasing awareness of CV disease in type 2 diabetics. FDA advisory committee strongly endorses new claim for the GLP-1 agonist but recommends limiting it to diabetics with established CV or chronic kidney disease.

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Novo Nordisk AS is setting the stage for a new cardiovascular benefit claim for the GLP-1 agonist Victoza (liraglutide) with a CV disease awareness campaign in the US. However, Novo’s requested labeling claim could be slimmed down if the FDA follows the advice of some of its external experts.

At a June 20 meeting, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 17-2 that results from the LEADER outcomes trial provided substantial evidence to establish

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