Therapy Areas: Cardiovascular
AstraZeneca's Bydureon receives positive CHMP opinion for BCise
2 July 2018 -

AstraZeneca Plc (LON:AZN), a science-led biopharmaceutical company, announced on Friday the adoption by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a positive opinion, recommending inclusion of Bydureon (2mg prolonged-release suspension for injection) BCise device as a new formulation within the marketing authorisation for Bydureon (exenatide extended-release) for the treatment of type-2 diabetes.

This new formulation of once-weekly Bydureon is an improved single-dose, pre -filled pen device, which in combination with other glucose-lowering medicines, including basal insulin, aims to help improve glycaemia control in adults with type-2 diabetes whose blood sugar levels are inadequately controlled by other glucose-lowering medicines together with diet and exercise.

The company said the CHMP recommendation is based on the clinical trials DURATION-NEO-1 and NEO -2. DURATION-NEO-1 is a 28-week, randomised, open-label, comparator-controlled trial (n=375), which showed that once-weekly Bydureon demonstrated an HbA1c reduction of 1.4% vs 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks (baseline HbA1c 8.5% and 8.4%, respectively).

Also, Bydureon administered once weekly via the BCise device demonstrated a mean weight reduction of 1.5 kilograms (kg) as monotherapy, as compared with a reduction of 1.9 Kg (baseline was 97 Kg) when combined with certain oral antidiabetic medicines.

This new formulation of once-weekly Bydureon (2mg prolonged-release suspension for injection) for the BCise device is approved by the US FDA.

AstraZeneca focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal & Metabolism and Respiratory. It is also selectively active in the areas of autoimmunity, neuroscience and infection.

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