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.