Astrazeneca Regulatory News (AZN)

29 June 2018 15:00 BST

Bydureon receives positive EU CHMP opinion for new BCise devicefor patients with type-2 diabetes

New formulation of once-weekly Bydureon in a pre-filled device recommended tohelp improve glycaemic control

AstraZeneca today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted 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.

The 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 glycaemic 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 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). Additionally, Bydureon administered once weekly via the BCise device demonstrated a mean weight reduction of -1.5 Kg as monotherapy, vs. -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.

About AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)

Cardiovascular, renal and metabolic diseases together form one of AstraZeneca's main therapy areas and platforms for future growth. By following the science to understand more clearly the underlying links between the heart, kidney and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities. Our ambition is to modify or halt the natural course of CVRM diseases and even regenerate organs and restore function, by continuing to deliver transformative science that improves treatment practices and cardiovascular health for millions of patients worldwide.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

For more information, please visit www.astrazeneca.com and follow us on Twitter @AstraZeneca.

Adrian KempCompany Secretary

AstraZeneca PLC