1. Pink Sheet

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

 
• By Sue Sutter

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.

A potential retinopathy risk with Novo Nordisk AS' semaglutide is clinically manageable and can be adequately handled through product labeling, a US FDA advisory committee said Oct. 18 in endorsing the drug's approval for type 2 diabetes.

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from US FDA Performance Tracker

More from Regulatory Trackers