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Novo's Semaglutide: Retinopathy Events Will Draw US FDA Panel's Focus

 
• By Sue Sutter

Once-weekly GLP-1 agonist was associated with higher risk of diabetic retinopathy complications in the SUSTAIN-6 trial, but Novo says this is consistent with data on early worsening of pre-existing retinopathy after glycemic control improves. While FDA's ophthalmology consultant concludes there's no cause for worry, clinical review team expresses 'residual concerns.'

Diabetes

A potential diabetic retinopathy risk with Novo Nordisk AS' semaglutide will be front and center at a US FDA advisory committee's review of the once-weekly, GLP-1 receptor agonist Oct. 18.

FDA is calling upon its Endocrinologic and Metabolic Drugs Advisory Committee to weigh an increased risk in diabetic retinopathy complications...

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