UK-based AstraZeneca has announced the availability of Qtern (saxagliptin and dapagliflozin fixed-dose combination) for adult patients with type 2 diabetes in the country.
The once-daily tablet saxa / dapa FDC combines saxagliptin 5mg, a dipeptidyl peptidase-4 (DPP-4) inhibitor, with dapagliflozin 10mg, a sodium-glucose co-transporter 2 (SGLT2) inhibitor.
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The tablet received marketing authorisation from the European Commission on 19 July last year and is indicated in adults aged 18 and older with type 2 diabetes in order to improve glycaemic control.
AstraZeneca UK country president Lisa Anson said: “Almost three-quarters (74%) of people with type 2 diabetes in the UK are not reaching the recommended HbA1c target of 6.5%, which means they are at increased risk of the complications associated with the condition.
“AstraZeneca is pleased to offer another treatment option in the diabetes portfolio to help patients reach their targets, enabling clinicians to continue oral therapy with a once-daily tablet.”
The European Commission approved the tablet based on data from three Phase III randomised, double-blind, active / placebo-control, parallel group, multi-centre clinical trials carried out in 1169 adult subjects with type 2 diabetes.
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By GlobalDataSaxa / dapa FDC can be used in patients with mild renal impairment and should be avoided in patients with moderate-to-severe renal impairment.
Patients with end-stage renal disease (ESRD) should avoid taking this tablet.
If used in combination with a sulphonylurea (SU), a reduction in the SU dose may be needed to minimise the risk of hypoglycemia.
The tablet is not licensed for weight loss or blood pressure reduction.
