FDA Approves Diabetes Combo


A once-daily dapagliflozin/saxagliptin tablet got FDA approval.

The US Food and Drug Administration (FDA) approved a new once-daily tablet that combines 10 mg of dapagliflozin and 5 mg of saxaglipton (QTERN/AstraZeneca) to treat type 2 diabetes mellitus. The product is meant to improve glycemic control in adults who have not achieved that with dapagliflozin alone--as well as patients who currently take the two drugs separately.

The product works by reducing the reabsorption of glucose and enabling its removal via urine.

SGLT-2 inhibitors including dapagliflozin have demonstrated reductions in HbA1c and have also been shown to result in weight loss and blood pressure reduction.

DPP-4 inhibitors reduce blood glucose.

The drug is not meant for t ype 1 diabetes or diabetic ketoacidosis.

Common adverse reactions include upper respiratory tract infection, urinary tract infection, and dyslipidemia.

QTERN is meant to be used as an adjunct to diet and exercise.

AstraZeneca made the announcement of the approval and also provided full prescribing information.

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