New Bydureon label update: EXSCEL now in US label

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

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.

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