astrazeneca_sign_sky

AstraZeneca’s Qtrilment scores European authorisation in type 2 diabetes

pharmafile | November 15, 2019 | News story | Medical Communications, Sales and Marketing AstraZeneca, EU, Europe, Qtrilmet, diabetes, pharma, type 2 diabetes 

Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) has secured approval in Europe, its manufacturer AstraZeneca has revealed, as a therapy to improve glycaemic control in adults with type-2 diabetes (T2D).

Specifically, the approval covers T2D patients who have not experienced adequate glycaemic control with metformin with or without sulphonylurea and in combination with either Onglyza or Forxiga, or in patients who are already receiving treatment with metformin, Onglyza and Forxiga.

Data from five Phase 3 trials supporting the application demonstrated that the combination of Forxiga (dapagliflozin) and Onglyza (saxagliptin), when used alongside metformin in patients with inadequately controlled type 2 diabetes, proved superior in reducing blood glucose levels compared to metformin paired with either Forxiga, Onglyza, or glimepiride.

This superior combo, with or without glimepiride, also proved itself non-inferior to the combination of insulin and metformin with or without glimepiride in blood glucose level reduction.

The European decision follows the drug’s US approval in March this year.

Matt Fellows

Related Content

AstraZeneca shares results for Imfinzi in phase 3 trial for small cell lung cancer

AstraZeneca has announced positive high-level results from the phase 3 ADRIATIC trial, which demonstrated that …

FDA accepts BLA for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for breast cancer treatment

AstraZeneca and Daiichi Sankyo have announced that their Biologics License Application (BLA) for datopotamab deruxtecan …

FDA approves AstraZeneca’s Ultomiris for NMOSD treatment

AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Ultomiris (ravulizumab-cwvs) …

Latest content