New Novo CVOT strategy; ADA ’18 Analyst Briefing
Novo hosted its annual ADA analyst briefing (presentation slides), predominantly discussing oral semaglutide. Of note, Novo disclosed they are no longer conducting a large-scale CVOT for Ozempic (formerly SOUL), instead leveraging the results of both SUSTAIN 6 and PIONEER 6 between injectable and oral semaglutide. Novo senior management said they believe it will be difficult for PIONEER 6 to demonstrate CV benefit at p < 0.05 given the low number of pre-specified events will require a large reduction in the hazard ratio. Additionally, Novo stated they plan to file oral semaglutide in mid-2019. Below are highlights from the ADA analyst event including three potential scenarios for injectable and oral semaglutide CV indications.
About The Author
Matthew has been a thought leader in the high-growth therapeutic areas of diabetes and cardiovascular medicine since 2006, making regular attendance at large and small CV/met scientific meetings and an architect of novel methods for assessing market opportunities. He has over a decade of experience in leading CV/met consulting engagements, is a published author in PM360 and Diabetes Technology & Therapeutics, and has been quoted in The Pink Sheet on anti-thrombotics.
If you receive our email blasts, you already have an account. Log in now
You can read the article’s full content online after purchase.