QTERN fixed-dose combination will provide an additional oral medicine option for patients taking FARXIGA® (dapagliflozin) to improve blood sugar level
AstraZeneca (NYSE:AZN) today announced that the US Food and Drug Administration (FDA) has approved once-daily QTERN® (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. The new medicine is indicated as an adjunct to diet and exercise to improve glycemic (blood sugar level) control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10mg) or who are already treated with dapagliflozin and saxagliptin.
Elisabeth Björk, Vice President, Head of Cardiovascular and Metabolic Diseases, Global Medicines Development at AstraZeneca, said: "Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 29 million people in the US alone. The approval of QTERN is good news for patients who may benefit from improved glycemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet.”
SGLT-2 inhibitors help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including FARXIGA® (dapagliflozin), have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c. FARXIGA is not indicated for weight loss or the treatment of hypertension.
QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. QTERN is contraindicated in patients with prior serious hypersensitivity reaction to QTERN or its components, patients with moderate to severe renal impairment, end stage renal disease, or on dialysis. The most common adverse reactions experienced were upper respiratory tract infection, urinary tract infection, and dyslipidemia.
INDICATION AND LIMITATIONS OF USE for QTERN® (dapagliflozin and saxagliptin)
QTERN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (T2DM) who have inadequate control with dapagliflozin or who are already treated with dapagliflozin and saxagliptin.
QTERN is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. QTERN should only be used in patients who tolerate 10 mg dapagliflozin.
IMPORTANT SAFETY INFORMATION for QTERN® (dapagliflozin and saxagliptin)
Contraindications
.Prior serious hypersensitivity reaction to QTERN or its components
.Moderate to severe renal impairment (eGFR <45 mL/min/1.73 m2), end-stage renal disease, or patients on dialysis
Warning and Precautions
.Pancreatitis: There have been postmarketing reports of acute pancreatitis in patients taking saxagliptin, and in the SAVOR cardiovascular outcomes trial. Observe for pancreatitis. If pancreatitis is suspected, discontinue QTERN
.Heart Failure: In the SAVOR cardiovascular outcomes trial, more patients treated with saxagliptin were hospitalized for heart failure compared to placebo. Patients with a prior history of heart failure or renal impairment had a higher risk for hospitalization for heart failure. Consider the risks and benefits of QTERN in patients who have known risk factors for heart failure. Monitor for signs and symptoms. If heart failure develops, consider discontinuation of QTERN
.