Novo Nordisk’s Liraglutide Gets Panel Nod For Weight Management
This article was originally published in The Pink Sheet Daily
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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US FDA does not raise any major concerns about study’s design or results to support cardiovascular risk reduction claim for Novo Nordisk’s GLP-1 agonist liraglutide ahead of advisory committee, but agency gives close scrutiny to non-CV safety events of interest.
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.
Liraglutide's US approval comes with a black box warning for a thyroid cancer risk and hefty post-marketing requirements.