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New Bydureon label update: EXSCEL now in US label

Here is a brief preview of this blast: Earlier this week, the Bydureon franchise label was updated to include 3 major changes: 1) CV safety data from EXSCEL, 2) a worse label restriction at an eGFR <45, up from <30, and 3) inclusion of acute gallbladder disease under warnings. Below, FENIX provides an analysis on the updated Bydureon label in comparison to the SUSTAIN-6 CV data from the Ozempic label, and why AZ may be able to infer in their field promotion that EXSCEL was superior despite the trial’s miss.

About The Author

Matthew Maryniak

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President of Fenix Group International
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.