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Medicines licensing

EMA approves combination treatment for type 2 diabetes

Fixed-dose saxagliptin/dapagliflozin combination lowers blood glucose levels in type 2 diabetes

A new combination therapy that can lower blood glucose levels in patients with type 2 diabetes is being recommended for marketing approval for some patients by the European Medicines Agency (EMA).

If the marketing authorisation goes ahead, Qtern (AstraZeneca), a fixed-dose combination of saxagliptin and dapagliflozin, will be the first treatment of its kind to be approved in Europe, the company says.

Saxagliptin is a dipeptidyl peptidase 4 inhibitor (DPP4-1) and works by reducing the cleavage and inactivation of the incretin hormone glucagon-like peptide 1. The drug increases incretin levels, which in turn stimulate glucose-dependent insulin secretion and inhibits the release of glucagon.

Dapagliflozin is an orally active inhibitor of the human sodium-glucose co-transporter 2 (SGLT2); it reduces renal glucose re-absorption leading to urinary glucose excretion.

The new combination therapy is being recommended to improve glycaemic control in type 2 diabetes patients only when metformin and/or sulphonylurea and one of the monocomponents of saxagliptin/dapagliflozin do not provide adequate glycaemic control. It is also being recommended for patients already being treated with the free combination of dapagliflozin and saxagliptin.

Patient charity Diabetes UK welcomes the approval. Dan Howarth, its head of care, says: “One of the many burdens people with type 2 diabetes face is the plethora of medications, not just for diabetes, [but] for a wide range of health needs. If someone is already taking saxagliptin and dapagliflozin, then as long as it safe to do so, a combination medication would be of benefit.

“Both DPP4-I and SGLT2 therapy has much evidence to support its use, both with minimal side effects,” he adds. “Having further options for people to successfully manage their type 2 diabetes is something that Diabetes UK supports.”

The recommendation to grant a marketing authorisation for the product follows a positive opinion by the EMA’s Committee for Medicinal Products for Human Use on 26 May 2016. The recommendation will now go to the European Commission for approval.

In October 2015, the US Food and Drug Administration (FDA), which is responsible for evaluating the safety and efficacy of medicines in the United States, refused a marketing authorisation for the same product.

The drug company confirmed at the time that, on the drug’s refusal, the FDA had asked it for additional clinical data. “This includes clinical trial data from ongoing or completed studies and may require information from new studies.”

Last year, AstraZeneca said it would work closely with the FDA to determine the next steps for the new drug application.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20201240

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