Posted by Michael Wonder on 25 Sep 2018
Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data
25 September 2018 - Label now includes data that demonstrated favourable cardiovascular safety profile for patients with type 2 diabetes mellitus at wide range of cardiovascular risk.
AstraZeneca today announced that the CHMP of the 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).
