Invokamet extended-release approved for diabetes

September 26, 2016

FDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014.

FDA recently approved an expanded use for Invokamet (Janssen): Invokamet XR, an extended-release combination drug to treat type 2 diabetes. The original Invokamet was approved by FDA in 2014.

The new once-daily, fixed-dose therapy combines canagliflozin (Invokana) and metformin hydrochloride extended-release medication to improve blood glucose control in adults with type 2 diabetes. Invokana is already the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million US prescriptions since its launch.

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“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., with Frist Clinic in Nashville, Tenn., in a Janssen statement. "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."

Invokamet XR is available in four dosages: in tablets containing canagliflozin 50 mg or 150 mg, and metformin XR 500 mg or 1,000 mg. The recommended dosing is two tablets once daily with the morning meal.

Phase 3 studies have shown that 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.

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Plus, the approved indication for Invokamet XR aligns with current type 2 diabetes treatment guidelines from the American Association of Clinical Endocrinologists and American College of Endocrinology and from the American Diabetes Association, which recommend dual therapy for patients with higher A1c levels.

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 2 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.

However, the prescribing information for Invokamet XR contains a boxed warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. In addition, Invokamet XR should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.

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