Xigduo is now available for use on NHS England and NHS Wales, as NICE and All Wales Medicines Strategy Group (AWMSG) have decided not to appraise it, on the basis that existing guidance for dapagliflozin already covers all patients for whom Xigduo would be clinically appropriate. AstraZeneca will submit Xigduo for an abbreviated appraisal by the Scottish Medicines Consortium (SMC).
Xigduo received Marketing Authorisation from the European Commission on 22nd January 2014. It 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. It 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.
“Dapagliflozin and metformin are commonly prescribed together as they have complementary mechanisms of action to help improve glycaemic control,” explained Prof John Wilding, Head of the Department of Obesity and Endocrinology at the University of Liverpool. “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”.
Dapagliflozin was the first medicine in the SGLT2 class to gain regulatory approval, having received European Marketing Authorisation for the treatment of type 2 diabetes in November 2012, and is currently approved for the treatment of type 2 diabetes in 40 countries.