FDA approves Invokamet XR (canagliflozin and metformin hydrochloride extended-release) for type 2 diabetes - Janssen Pharma

Janssen Pharmaceuticals announced the FDA has approved Invokamet XR�a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release (XR)�for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate. Invokamet XR combines INVOKANA (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since launch, and an XR formulation of metformin. Metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.

Phase III studies have shown the combination of Invokana and metformin reduces A1C significantly more than metformin alone, sitagliptin plus metformin, or glimepiride plus metformin. Treatment with Invokana as an add-on to metformin also demonstrated greater reductions in the secondary endpoints of body weight and systolic blood pressure. Studies in healthy adults have demonstrated that administration of Invokamet XR results in the same levels of canagliflozin and metformin XR in the body as when corresponding dosages of the two medicines are administered as separate tablets. Canagliflozin works with the kidneys to help adults with type 2 diabetes lose some sugar through the process of urination, and metformin decreases the production of glucose in the liver and improves the body's response to insulin. Invokamet XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.