After first rejecting it at the end of 2015, the FDA has now approved the AstraZeneca DPP-4 inhibitor/SGLT2 inhibitor fixed-dose combination product Qtern for type 2 diabetes in adults. - From Medscape
The US Food and Drug Administration (FDA) has approved a once-daily oral fixed-dose medication, called Qtern, combining 5 mg of the DPP-4 inhibitor saxagliptin (Onglyza, AstraZeneca) and 10 mg of the SGLT2 inhibitor dapagliflozin (Forxiga/Farxiga, AstraZeneca) for the treatment of type 2 diabetes in adults, according to a news release from AstraZeneca.
The US agency did, however, approve a combination of the DPP-4 inhibitor linagliptin (Tradjenta) and SGLT2 inhibitor empagliflozin (Jardiance), known as Glyxambi, developed by Boehringer Ingelheim/Eli Lilly in February 2015.
SGLT2 inhibitors help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine; in trials, they have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure.
And last June the FDA strengthened warnings for dapagliflozin, along with another SGLT2 inhibitor, canagliflozin (Invokana, Janssen) related to acute kidney injury.
And saxagliptin has a warning on the US label cautioning that it may increase the risk for heart failure, particularly in patients who already have cardiovascular or kidney disease, based on findings from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus–Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53).