FDA Approves New Option for Type 2 Diabetes (INVOKAMET XR)

The U.S. Food and Drug Administration (FDA) has approved INVOKAMET XR for first-line use as a supplement to diet and exercise to better control blood glucose in adults with type 2 diabetes.

INVOKAMET XR is a once-daily, fixed-dose combination therapy of canagliflozin—the most prescribed sodium glucose cotransporter 2 inhibitor (INVOKANA)—and metformin hydrochloride extended-release.

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Current guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology and from the American Diabetes Association recommend dual therapy for patients with A1C levels higher than 7.5% and for those who have an initial level below 7.5% and do not achieve an A1C treatment goal after about 3 months on single therapy. INVOKAMET XR aligns with these guidelines.

The medication is available in 4 dosages: 50 mg or 150 mg canagliflozin tablets and 500 mg or 1000 mg metformin XR tablets. The recommended dose is 2 tablets with the morning meal.

There is a boxed warning for lactic acidosis, which can result from metformin accumulation.

“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, MD, of Frist Clinic in Nashville, Tennessee. “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.”

—Amanda Balbi

Reference:

U.S. FDA approves INVOKAMET® XR (canagliflozin/metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes [news release]. Raritan, NJ: Janssen Pharmaceuticals; September 21, 2016. http://www.janssen.com/us-fda-approves-invokamet-xr-canagliflozin-metformin-hydrochloride-extended-release-treatment-adults. Accessed September 21, 2016.