FDA approves new combination Type 2 diabetes drug Glyxambi

diabetes illus250x03 FDA approves new combination Type 2 diabetes drug GlyxambiThe Food and Drug Administration (FDA) has approved Glyxambi, a new treatment for Type 2 diabetes that combines two previously approved diabetes drugs, empagliflozin (marketed as Jardiance) and linagliptin (sold as Tradjenta). Glyxambi is the first and only diabetes treatment in the U.S. to combine the dual mechanisms of a sodium glucose co-transporter-2 (SGLT2) inhibitor (Jardiance) and a dipeptidyl peptidase-4 (DPP-4) inhibitor (Tradjenta) in a tablet, which is taken once every morning.

SGLT2 inhibitors work by removing glucose through the urine by blocking blood glucose re-absorption in the kidneys. DPP-4 inhibitors work by increasing hormones that stimulate the pancreas to produce more insulin and simulate the liver to produce less glucose.

Glyxambi was approved based on clinical trials involving patients whose diabetes was not controlled by metformin, which showed significantly greater reductions in blood glucose levels compared to Jardiance or Tradjenta alone.

Both SGLT2 inhibitors and DPP-4 inhibitors are in a newer class of type 2 diabetes drugs known as incretin mimetics. These drugs, in particular Byetta and Januvia, have been shown to inflame the pancreas leading to a painful condition known as acute pancreatitis. They have also been linked to pancreatic cancer.

The safety label for Glyxambi will state that the drug has not been studied in patients with a history of pancreatitis, and it is unknown if using Glyxambi increases the risk of developing pancreatitis in these patients.

Source: PharmPro