AstraZeneca has 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 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 the European label.
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).
Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: “We are pleased with this positive recommendation for Bydureon and what it means for patients with type-2 diabetes with a wide range of cardiovascular risk. Our pursuit of this label is based on our strong belief in the clinical value the EXSCEL data brings to physicians and patients.”
The full results of EXSCEL have been published in the New England Journal of Medicine.