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).
“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,” says Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolic Diseases, Global Medicines Development at AstraZeneca.
The full results of EXSCEL have been published in the New England Journal of Medicine.
Marketing authorisation for Imfinzi
Earlier this week, the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial.
“Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease,” said Dave Fredrickson, Executive Vice President, Head of the Oncology Business.
The most common adverse reactions (greater than or equal to 20% of patients) of Imfinzi versus placebo were cough (40.2% vs. 30.3%), upper respiratory tract infections (26.1% vs 11.5%) and rash (21.7% vs 12.0%). 12.8% of patients experienced a grade 3 or 4 AE with Imfinzi vs 9.8% with placebo.
Imfinzi is approved for the treatment of patients with unresectable, Stage III (locally-advanced) NSCLC in the US, Canada, Switzerland, India, Japan and Brazil. Other global health authority reviews and submissions are ongoing.