The Food and Drug Administration (FDA) approved Qtern, a new type 2 diabetes treatment that contains 5 mg of the DPP-4 inhibitor saxagliptin (known by the brand name Onglyza) and 10 mg of the SGLT2 inhibitor dapagliflozin (Farxiga). The medication is for patients who did not have adequate glycemic control with dapagliflozin alone or who were already taking dapagliflozin and saxagliptin.
The FDA had rejected Qtern in late 2015 because reviewers didn’t think there was enough evidence to support its approval, despite giving clearance to a different DPP-4 inhibitor/SGLT2 inhibitor – Glyxambi – earlier that year. Qtern was approved by European drug regulators in May 2016.
Qtern offers diabetics another treatment option, but does not eliminate the risk of undesirable side effects associated with both drugs. SGLT2 inhibitors, which include brand-name drugs Invokana and Invokamet, have been hit with strengthened or updated warnings including serious urinary tract infections, bone density loss, bone fracture risk, acute kidney injury and ketoacidosis, a serious condition in which too much acid builds up in the blood. The drugs are also being investigated for possibly increasing the risk of lower limb amputations, particularly of the foot and toes.
Saxagliptin has also been associated with an increased risk of heart failure, particularly among patients who already have cardiovascular or kidney disease, and can increase the risk for a painful inflammation of the pancreas known as acute pancreatitis.