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AZ gets US green light for new Bydureon formulation

Its latest injectable suspension proven to reduce blood sugar levels

Bydureon

AstraZeneca’s newly formulated Bydureon BCise (exenatide extended-release) has received US approval from the Food and Drug Administration (FDA) for adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines.

The once-weekly, single-dose auto injector device is an improved version of AZ’s Bydureon - which the British group acquired from Bristol Myers Squibb back in 2013 - and originally required a six-step preparation and administration process.

However, AZ’s latest version of the product is said to “help enhance the patient experience” and although not a weight management medicine, the product has “an added benefit” of weight reduction.

Ruud Dobber, president, AstraZeneca US, said: “With the approval of Bydureon BCise, we’re now introducing a new formulation in an improved, easy-to-use device.

“We know that physicians have established longstanding confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss.”

Set across two clinical trials, patients on Bydureon BCise saw average glycated haemoglobin (HbA1c) reductions of up to 1.4% and average weight loss reductions of up to 3.1 pounds when the injectable was used as monotherapy or as an add-on.

The new formulation also has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient exenatide, which is said to help patients reach and maintain a steady state.

Bydureon BCise will be available for patients in the US in the first quarter of 2018 and AZ have filed an application to the European Medicines Agency for approval within the EU.

Article by
Gemma Jones

24th October 2017

From: Regulatory

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