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FDA Clears Victoza, But Warnings And More Studies Pose Hurdles

This article was originally published in The Pink Sheet Daily

Executive Summary

Liraglutide's US approval comes with a black box warning for a thyroid cancer risk and hefty post-marketing requirements.

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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.

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.

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

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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