EASD 2016: Semaglutide Steals The Show With Impressive Cardiovascular Outcomes Data
New data from Novo Nordisk supporting its GLP-1 agonist will fortify the firm's new drug applications, strengthen its position in price negotiations and boost its chances of reimbursement.
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Novo Nordisk’s chief science officer tells Scrip the readout of its PIONEER 6 trial on oral semaglutide came earlier than originally thought, allowing for an FDA filing in first-half 2019, and that use of a priority review voucher is a clear option that could speed up the process.
Long-term top-line market forecasts for Novo Nordisk are heavily reliant on its GLP-1 portfolio's potential - so pricing uncertainties, especially in the US, can unnerve sentiment, as seen when it reported Q2 results.
Novo's oral GLP-1 receptor agonist has a lot going for it in diabetes based on the latest data, but still needs to prove cardiovascular benefit; a new large outcomes study is now in the works.