AstraZeneca has launched its twice-daily tablet Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) in the UK to treat patients with type 2 diabetes.
Xigduo is the first fixed-dose combination of Forxiga (dapagliflozin), a selective and reversible inhibitor of SGLT2, and metformin hydrochloride (HCI), to be available in the UK.
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The tablet is currently available for use on NHS England and NHS Wales only, as the National Institute for Health and Care Excellence (NICE) and All Wales Medicines Strategy Group (AWMSG) have decided not to appraise it, on the basis that the current guidance for dapagliflozin already covers all patients that Xigduo would be clinically suitable for.
The company also seeks abbreviated appraisal from the Scottish Medicines Consortium (SMC) for its Xigduo.
In January 2014, the company has secured marketing authorisation for Xigduo from the European Commission (EC).
The medicine is indicated for use in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control.
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By GlobalDataIt is also indicated for use in patients inadequately controlled on their current metformin-based treatment regimen, or who are currently being treated with the combination of dapagliflozin and metformin as separate tablets.
The University of Liverpool’s Department of Obesity and Endocrinology head John Wilding said dapagliflozin and metformin are commonly prescribed together as they have complementary mechanisms of action to help improve glycaemic control.
"Being available together in a single tablet provides us with another treatment option to offer our type 2 diabetes patients, which is welcome as the need to individualise diabetes care is becoming increasingly important," Wilding said.
The company said that Forxiga (dapagliflozin) was the first medicine in the SGLT2 class to get regulatory approval, having previously received European marketing authorisation for the treatment of type 2 diabetes, and is currently approved for the treatment of type 2 diabetes in 40 countries.
AstraZeneca president of UK and Ireland Lisa Anson said: "There are almost three million people in the UK living with type 2 diabetes and this latest development reinforces AstraZeneca’s long-term commitment to being at the forefront of providing them and the healthcare professionals that treat them, with medicines to manage this increasingly prevalent disease."
In the UK, around 2.88 million people are estimated to be living with type 2 diabetes and a further 765,000 people are thought to have undiagnosed type 2 diabetes.
Image: AstraZeneca’s Xigduo secured Marketing Authorisation from the European Commission in January. Photo: courtesy of AstraZeneca.
