New combo drug approved for T2DM

FDA has approved Invokamet, a fixed-dose therapy combining canagliflozin and metformin HCl in a single tablet, to treat adults with type 2 diabetes, according to the maker of the drug.

Janssen Pharmaceuticals said Invokamet provides the clinical attributes of canagliflozin, the first sodium glucose co–transporter 2 (SGLT2) inhibitor available in the United States, with metformin, commonly prescribed early in the treatment of type 2 diabetes.

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“Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes,” said Richard Aguilar, MD, medical director of Diabetes Nation. “Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body's response to insulin.”

The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications. It should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

Janssen said Invokamet will be available in tablets containing canagliflozin 50 mg or 150 mg, and metformin 500 mg or 1000 mg. The recommended dosing is twice daily. The drug also contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.