The Food and Drug Administration (FDA) has approved Xigduo, a new once-daily treatment for type 2 diabetes. Xigduo is a combination of an extended release version of the long-used diabetes drug metformin and dapagliflozin, a diabetes drug recently approved by the FDA and marketed under the name Farxiga.
Xigduo is the first and only once-daily combination oral medication of an SGLT2 inhibitor and an extended release version of metformin to be approved in the United States. The drug is intended to be used in combination with exercise and diet to improve glycemic control in adults with type 2 diabetes.
The drug will hit the market with a black box warning for lactic acidosis, a rare but serious metabolic complication that can occur if there is an accumulation of metformin during treatment.
Dapagliflozin is a member of a relatively new family of drugs known as SGLT2 inhibitors. These drugs are in a class known as incretin mimetics, which also includes type 2 diabetes medications Januvia and Byetta. Both Januvia and Byetta have been linked to a painful inflammation of the pancreas called acute pancreatitis, as well as an increased risk of pancreatic cancer.
Dapagliflozin, marketed as Farxiga, was approved in January. In October, the drug’s label was updated to include a warning for an increased risk of bladder cancer.
The type 2 diabetes drug Actos has also been linked to bladder cancer. In April, Takeda Pharmaceuticals, maker of Actos, and partner Eli Lilly, were ordered to pay $9 billion in punitive damages to a couple who claimed Takeda covered up bladder cancer risks with Actos use.