Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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

Executive Summary

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...



Keeping Track: Approvals, A Burst Of Submissions, And Some Priority Reviews

The latest drug development news and highlights from our US FDA Performance Tracker.

Semaglutide Retinopathy Risk No Bar To Approval, US Panel Says

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.

Smooth AdCom Passage Expected For Novo's Semaglutide Despite Retinopathy Queries

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133990

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel