August 11, 2014
1 min read

FDA approves canagliflozin/metformin combination tablet for type 2 diabetes

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The FDA announced its recent approval of a canagliflozin/metformin combination tablet to reduce blood glucose in adults with type 2 diabetes.

Invokamet (canagliflozin/metformin HCl, Janssen Pharmaceuticals, Inc) pairs the sodium glucose co-transporter 2 (SGLT2) inhibiting action of canagliflozin (Invokana, Janssen) with metformin.

The canagliflozin/metformin combination tablet will be available in doses containing canagliflozin 50 mg or 150 mg, and metformin 500 mg or 1000 mg, with two recommended daily doses.

The approval follows the FDA’s inquiry in late 2013 to establish differences between the previously approved monotherapy canagliflozin and the new combination treatment.

The combination tablet was studied in six phase 3 clinical trials, with data from 4,732 patients with type 2 diabetes. The combination drug was demonstrated to lower blood glucose, with additional secondary endpoints of reducing weight and systolic blood pressure, the press release said.

“Invokamet combines, in one tablet, two complementary therapeutic approaches proven effective for managing type 2 diabetes,” Richard Aguilar, MD, Medical Director of Diabetes Nation, said in a press release. “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 most common side effects were female genital fungal infections, urinary tract infections and increased urination, according to the press release.

For more information, read the press release from Janssen Pharmaceuticals, Inc.