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

 
• By Lucie Ellis-Taitt

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.

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Novo's semaglutide is speeding towards US launch before end of 2017 • Source: Shutterstock

Novo Nordisk AS' experimental once-weekly GLP-1 inhibitor semaglutide will face its first US FDA advisory committee on Oct. 18 – the type 2 diabetes treatment is forecast to move easily through the proceedings despite some safety concerns around diabetic retinopathy complications.

The FDA's Endocrinologic and Metabolic Drugs Advisory Committee is expected to question Novo about the increased risk in diabetic retinopathy complications seen in the SUSTAIN-6 trial. The company says the higher number of events seen in this semaglutide clinical study resulted from the rapid and large reductions in hemoglobin A1C produced by the drug in a high-risk population

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