AstraZeneca gains EU clearance of triple-combination therapy Qtrilmet for type 2 diabetes

AstraZeneca said Friday that the European Commission approved Qtrilmet, a once-daily medicine that combines the SGLT-2 inhibitor Farxiga (dapagliflozin) plus the DPP‑4 inhibitor Onglyza (saxagliptin) with extended-release metformin, to treat type 2 diabetes in adults. The therapy was approved in the US in May under the name Qternmet XR.

The EU approval was based on data from five Phase III trials that evaluated combinations of Forxiga and Onglyza on a background of metformin in patients with inadequately controlled type 2 diabetes. The primary endpoint in all the studies was mean change from baseline in HbA1c levels at week 24 or week 52.

According to AstraZeneca, Qtrilmet was superior at lowering HbA1c across the trials when compared against metformin used in combination with Forxiga, with Onglyza or with the sulphonylurea drug glimepiride. Qtrilmet, with or without glimepiride, also showed non-inferiority at reducing HbA1c versus the combined use of insulin plus metformin, with or without glimepiride.

The decision follows a positive opinion for Qtrilmet reached in September by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

The dual combination of Farxiga and Onglyza was approved by regulators in Europe and the US under the name Qtern in 2016 and 2017, respectively.

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