Novo's Semaglutide: Retinopathy Events Will Draw US FDA Panel's Focus
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.'
You may also be interested in...
The latest drug development news and highlights from our US FDA Performance Tracker.
Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.
Novo Nordisk's Victoza follow-on semaglutide, forecast to become the third once-weekly GLP-1 product available on the highly competitive US diabetes market, is expected to secure a market-leading spot, by revenue, before 2025.