AstraZeneca improves diabetes pen to maintain its market share

The European Commission (EC) has approved AstraZeneca’s Bydureon BCise, a new weekly formulation of established GLP-1 diabetes drug with the added benefit of glucose reduction, better weight loss results and a new injection pen.  

AstraZeneca announced that the EC green-lighted the new formulation of the once-weekly type-2 diabetes injection, which will be marketed as Bydureon BCise (exenatide 2mg prolonged-release suspension).

The new authorisation has been granted for a single-dose, pre-filled pen device that requires no titration and is approved for use in combination with other glucose-lowering medicines, including basal insulin, to help improve glycaemic control together with diet and exercise.

The EC made its decision based on data from DURATION-NEO-1 clinical trial comparing Bydureon BCise and AZ'[s twice-daily exenatide formulation, Byetta. After 28 weeks of treatment, patients administered with the new formulation demonstrated an HbA1c reduction of 1.4% and 1% respectively.

Additionally, Bydureon BCise demonstrated a mean weight reduction of 1.5 Kg as monotherapy comparing to 1.9 Kg with certain oral antidiabetic medicines.

Elisabeth Björk

Elisabeth Björk

Elisabeth Björk, vice president, head of cardiovascular, renal and metabolism, global medicines development at AstraZeneca, 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.”

This new formulation of once-weekly Bydureon BCise has been already approved in the US by the Food and Drug Administration (FDA) in October 2017 and hit the market in the first quarter of this year.

Despite improvements Bydureon’s will still face stiff competition to sustain its established drug share on the GLP-1 market.

Novo Nordisk recently published the first promising PIONEER 5 trial results for oral semaglutide, and also claim that its current Ozempic shows the greater levels of blood sugar and weight reduction when compared with Bydureon and Eli Lilly’s Trulicity.

Market analysts suggest that Novo Nordisk will be able to add another blockbuster to its portfolio and further billions to its revenue should semaglutide get approved in a daily pill form.

Also, the small Israeli biotech Oramed is developing an oral version of exenatide – the active ingredient in AstraZeneca’s Byetta, but this drug is still in mid-stage trials.

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