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FDA Panel To Weigh Relevance Of Liraglutide’s Diabetes Experience In Obesity

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency will ask external advisors Sept. 11 how the GLP-1 agonist’s safety in type 2 diabetes, approved as Victoza in 2010, informs the safety profile in obesity, where Novo Nordisk is seeking a higher dose and a different name.

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Novo Nordisk’s Liraglutide Gets Panel Nod For Weight Management

Advisory committee members are generally comfortable with use of the GLP-1 receptor agonist in the first-line setting, suggesting that a second-line treatment restriction in diabetes could be lifted.

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