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Semaglutide's CHMP Backing Stipulates Post-Approval Safety Studies

 
• By Sten Stovall

Novo Nordisk's once-weekly diabetes treatment semaglutide wins backing from EMA's top advisory panel one week after the GLP-1 agonist was approved in the US, the first country to do so. Safety studies have been required.

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Novo Nordisk's Ozempic (semaglutide) Gets Recommended For Approval By EMA's CHMP • Source: Shutterstock

Novo Nordisk AS has committed to conducting post-approval safety studies on semaglutide - including a long-term diabetic retinopathy outcome study - in return for regulatory backing for the GLP-1 therapy in Europe.

Ozempic, semaglutide's proposed brand name, is a glucagon-like peptide 1 (GLP-1) receptor agonist designed to improve glycemic control in adults, along with diet and exercise, in patients with type 2...

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