AstraZeneca has secured marketing authorisation from the European Commission (EC) for its Bydureon BCise device to treat patients with type-2 diabetes.
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Bydureon BCise is an exenatide 2mg prolonged-release suspension for injection in pre-filled pen.
It has been approved as a new formulation for Bydureon (exenatide extended release) to treat type-2 diabetes patients.
The new formulation of once-weekly Bydureon is an enhanced single-dose and pre-filled pen device, which needs no titration.
The approval was granted for use in combination with other glucose-lowering medicines such as basal insulin.
Bydureon BCise will enable to 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 approval was based on data from two clinical trials, including Duration-Neo-1 and Neo-2.
Duration-Neo-1 is a 28-week, randomised, open-label and comparator-controlled trial, which demonstrated that once-weekly Bydureon BCise showed an HbA1c reduction of 1.4% against 1.0% for twice-daily Byetta (exenatide) injection at 28 weeks
Bydureon BCise also showed a mean weight reduction of -1.5kg as monotherapy against 1.9kg when combined with certain oral antidiabetic medicines.
In October 2017, the US Food and Drug Administration (FDA) granted approval for the new formulation of once-weekly Bydureon BCise.
AstraZeneca cardiovascular, renal and metabolism global medicines development head and vice president Elisabeth Björk said: “Building on the already well-established efficacy and safety profile of once-weekly Bydureon, today’s approval of Bydureon BCise will enable us to offer an additional treatment option for patients with type-2 diabetes whose blood sugar levels are inadequately controlled by other glucose-lowering medicines together with diet and exercise.”
In April this year, Owlstone Medical agreed to provide breath biopsy services to AstraZeneca to study disease drivers in asthma and COPD.
Under the service agreement, AstraZeneca can access Owlstone’s breath biopsy services, including the development of classification algorithms that identify breath biomarkers for precision medicine applications across asthma and COPD.
AstraZeneca is a science-led biopharmaceutical firm, which is engaged in the discovery, development and commercialisation of prescription medicines for oncology, cardiovascular, renal and metabolism and respiratory.