Bydureon EU label to Include All-Cause Mortality Data from EXSCEL

AstraZeneca announced Bydureon received a positive CHMP opinion to include EXSCEL CVOT data in the EU label. Importantly, the CHMP opinion also recommends inclusion of the pre-specified all-cause mortality secondary outcome data, which demonstrated a 14% RRR. Below, FENIX provides thoughts on the CHMP opinion and insight into potential read-through to a US Bydureon label update.

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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