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FDA approves type 2 diabetes treatment Invokamet

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The U.S. Food and Drug Administration has approved Janssen Pharmaceuticals Inc.'s Invokamet to treat adults with type 2 diabetes. Invokamet is a fixed-dose therapy combining canagliflozin (Invokana) and metformin hydrochloride in one tablet. Canagliflozin was approved by the FDA in March 2013 and is a sodium glucose co-transporter 2 (SGLT2) inhibitor.

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.

Phase III studies showed that Invokametlowered blood sugar and reduced secondary endpoints of body weight and systolic blood pressure to a greater degree than metformin alone.