CHMP positive for update of Bydureon label to refer to lowering of CV risk. AstraZeneca

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion on a Type-II variation update for Bydureon (exenatide extended-release), to include in the European label cardiovascular (CV) data from the EXSCEL (EXenatide Study of Cardiovascular Event Lowering) trial in adults with type-2 diabetes at a wide range of CV risk.

In EXSCEL, Bydureon did not increase the incidence of major adverse cardiovascular events (MACE), a composite endpoint of CV death, non-fatal heart attack (myocardial infarction) or non-fatal stroke, compared to placebo (Hazard Ratio [HR]: 0.91; 95% Confidence Interval [CI]: 0.83-1.00; p<0.001 for non-inferiority). although the primary efficacy objective of a superior reduction in mace narrowly missed statistical significance (p="0.061)," there were fewer cv events observed in the bydureon arm of the trial (839 [11.4%] versus 905 [12.2%]).>

The prespecified secondary analysis on all-cause mortality has also been accepted for inclusion in the European label. Patients on Bydureon had a 14% lower incidence of all-cause mortality compared to usual care alone (HR: 0.86; 95% CI: 0.77-0.97). The full results of EXSCEL have been published in the New England Journal of Medicine in September 2017.