AstraZeneca gets EC approval for type-2 diabetes treatment
By Josh White
Date: Friday 15 Nov 2019
(Sharecast News) - AstraZeneca announced on Friday that the European Commission has approved 'Qtrilmet' - metformin hydrochloride, saxagliptin and dapagliflozin - modified-release tablets to improve glycaemic control in adults with type-2 diabetes.
The FTSE 100 pharmaceuticals giant said the approval was based on data from five phase 3 trials, which evaluated combinations of 'Forxiga' - dapagliflozin - and Onglyza - saxagliptin - on a background of metformin in patients with inadequately-controlled type-2 diabetes.
It said the primary endpoint in those trials was mean change from baseline in average blood glucose levels at week 24 or 52.
Across the trials, the combination of Forxiga, Onglyza and metformin was found to be superior at reducing average blood glucose levels, compared to Forxiga with metformin, Onglyza with metformin, or glimepiride - an approved type-2 diabetes sulphonylurea medicine - with metformin.
The company said the combination of Forxiga, Onglyza and metformin with or without glimepiride showed non-inferiority in reducing average blood glucose levels compared to the combined use of insulin and metformin with or without glimepiride.
It added that the safety results of the individual medicines in the trials were consistent with their known profile.
"The EC has approved Qtrilmet to improve glycaemic control in adults with type-2 diabetes when metformin with or without sulphonylurea and either Onglyza or Forxiga does not provide adequate glycaemic control, or when type-2 diabetes patients are already being treated with metformin, Onglyza and Forxiga," the AstraZeneca board explained in its statement.
Qtrilmet was approved in the United States in May under the name 'Qternmet XR', as an adjunct to diet and exercise to improve glycaemic control in adults with T2D.
At 0839 GMT, shares in AstraZeneca were up 0.34% at 7,341p.
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