Novo's Semaglutide: Retinopathy Warning Unlikely To Dim Commercial Prospects
Executive Summary
Sponsor's proposal for a label warning, but not a black box, on retinopathy risk with the once-weekly GLP-1 agonist finds support from a US FDA advisory committee, which overwhelming endorsed approval for treatment of type 2 diabetes on the basis of robust glycemic control efficacy data and a strong cardiovascular safety profile.
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.
Novo Nordisk Plans Value-based Contracts For GLP-1 Agonist Ozempic
Company aims to shift gradually away from once-daily GLP-1 Victoza (liraglutide) toward once-weekly Ozempic (semaglutide).
EU CHMP To Decide On New Drugs For Asthma, Diabetes, Hemophilia A, Ovarian Cancer – And Roche’s Ocrevus
Products for a wide range of diseases are expecting a CHMP opinion this week, including orphan drugs for ovarian cancer, eosinophilic esophagitis, and CMV infection, and therapies for asthma, diabetes, and hemophilia A. Roche will be hoping its multiple sclerosis drug Ocrevus can finally clear the CHMP hurdle.