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U.S. FDA Approves Janssen’s INVOKAMET® XR

 

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Janssen Pharmaceuticals, Inc. (Janssen) announced the U.S. Food and Drug Administration (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.

“INVOKAMET® XR offers the convenience of once-daily dosing and provides physicians needed flexibility for tailoring treatment to the needs of type 2 diabetes patients, especially those with higher A1C levels,” said John Anderson, M.D.,* Frist Clinic, Nashville, Tenn. “As with INVOKAMET®, physicians can prescribe the XR formulation to adults when they are first diagnosed with type 2 diabetes or as additional therapy for people whose A1C levels are not well controlled with either agent alone.”

Phase 3 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.

“The approval of INVOKAMET® XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes,” said Paul Burton, M.D., Ph.D., Vice President, Medical Affairs, Janssen. “Our INVOKANA® portfolio now offers physicians even more choices for helping patients improve control of A1C levels and other important health measures, with numerous dosing options for monotherapy and for combination therapy with both metformin and metformin XR.”
INVOKAMET® XR is available in four dosages, in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin XR 500 mg or 1000 mg. The recommended dosing is two tablets once daily with the morning meal. The prescribing information for INVOKAMET® XR also contains a boxed warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation.

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.

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