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Novo Nordisk Using Priority Review Voucher To Propel Oral Semaglutide To Market

 
• By Sten Stovall

Danish diabetes fighter will file oral semaglutide with FDA within months using a priority review voucher to reduce the time for expected approval to six months.

Track
Novo Nordisk Aims to cut FDA review time to six months for its oral GLP-1. • Source: Shutterstock

Prospects of a 2020 market arrival for Novo Nordisk AS’s ground-breaking oral GLP-1 diabetes therapy remain on track, propelled by solid clinical trial data and a priority review voucher purchased by the Denmark-based group to speed the process.

Regulatory plans for oral semaglutide were announced along with the company’s fourth-quarter and full-year update for fiscal 2018, which although...

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