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news.AstraZeneca has introduced Xigduo (dapagliflozin and metformin hydrochloride in 5mg/850mg and 5mg/1000mg tablets) in the UK for the treatment of appropriate patients with type 2 diabetes.
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The twice daily tablet ‘Xigduo’ that combines Forxiga (dapagliflozin), a selective and reversible inhibitor of SGLT2, with metformin hydrochloride (HCI), is the first fixed-dose combination of its kind to be available in the UK.
The medicine is now available for use on NHS England and NHS Wales, 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 for whom Xigduo would be clinically appropriate.
AstraZeneca also intends to submit Xigduo for an abbreviated appraisal by the Scottish Medicines Consortium (SMC).
In January 2014, the company has got marketing authorization from the European Commission (EC) for Xigduo, which 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.
The drug is 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 company said that Forxiga (dapagliflozin) was the first medicine in the SGLT2 class to get regulatory approval, having received European marketing authorization 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 that the company happy to have launched the first in class SGLT2 inhibitor – dapagliflozin – for the treatment of type 2 diabetes, a the first fixed-dose combination of SGLT2 and metformin.
"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," Lisa Anson.
Image: AstraZeneca will submit Xigduo for an abbreviated appraisal by the Scottish Medicines Consortium (SMC). Photo: courtesy of AstraZeneca