Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data
- Category: Proteins and Peptides
- Published on Wednesday, 26 September 2018 09:42
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Label now includes data that demonstrated favourable cardiovascular safety profile for patients with type-2 diabetes at wide range of cardiovascular risk
LONDON, UK I September 25, 2018 I AstraZeneca today 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).
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.”
NOTES FOR EDITORS
The positive CHMP opinion to include cardiovascular data from the EXSCEL trial in the European label for Bydureon can be implemented without the need for an immediate European Commission decision due to the nature of the amendment, which is a Type-II variation.
EXSCEL is a Phase IIIb/IV, double-blinded, placebo-controlled, global CV outcomes trial conducted in 35 countries and enrolled 14,500 patients with type-2 diabetes with or without additional CV risk factors or prior CV events. Overall, 73% of included patients had experienced at least one prior CV event, whereas 27% had not. Participants were randomised to receive exenatide 2mg once-weekly or matching placebo by subcutaneous injections. EXSCEL was run jointly by two academic research organisations: the Duke Clinical Research Institute (Durham, NC, US) and the University of Oxford Diabetes Trials Unit (Oxford, UK).
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