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Bydureon receives positive CHMP opinion for BCise
Bydureon receives positive CHMP opinion for BCise.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 1042T AstraZeneca PLC 29 June 2018 \n\n29 June 2018 15:00 BST\n \nBydureon receives positive EU CHMP opinion for new BCise device\nfor patients with type-2 diabetes \n \nNew formulation of once-weekly Bydureon in a pre-filled device recommended to\nhelp improve glycaemic control \n \nAstraZeneca 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.\n \nThe 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.\n \nThe 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. \n \nThis new formulation of once-weekly Bydureon (2mg prolonged-release suspension for injection) for the BCise device is approved by the US FDA.\n \nAbout AstraZeneca in Cardiovascular, Renal & Metabolism (CVRM)\nCardiovascular, 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 ...