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.