FDA Expands Indication of INVOKAMET (canagliflozin/metformin HCl) to Include First-Line Treatment of

 

INVOKAMET®, the first combination of a sodium glucose co–transporter 2 (SGLT2) inhibitor and metformin available in the United States, was previously approved by the FDA in August 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes not adequately controlled by either canagliflozin or metformin, or who are already being treated with both medications separately.

“Physicians increasingly try to achieve greater initial blood sugar control by using dual therapy at the outset, versus single-agent therapy alone, especially for patients with higher A1C levels,” said John Anderson, M.D.*, Frist Clinic, Nashville, Tenn. “INVOKAMET® combines two effective, complementary medicines—canagliflozin and metformin—into one convenient pill, to lower A1C significantly more than metformin alone.”

A1C is a measure of average blood glucose over the past two to three months; the American Diabetes Association recommends most adults with type 2 diabetes maintain A1C levels of 7 percent or less.2

The new INVOKAMET® indication aligns with recent type 2 diabetes treatment guidelines, which recommend dual therapy for patients with higher A1C levels. Specifically, guidelines recommend dual therapy for patients who have an initial A1C level of 7.5 percent or higher;3 and for those who have an initial level below 7.5 percent and do not achieve an A1C treatment goal after about three months on single therapy, often metformin.3,4 In addition, dual or triple therapy is recommended as first-line therapy in asymptomatic patients with an initial A1C level above 9 percent.3

Studies have demonstrated that administration of INVOKAMET® results in the same levels and effects of canagliflozin and metformin in the body as co-administration of corresponding doses of both drugs as individual 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® should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.1

INVOKAMET® is available in four dose strengths, in tablets containing canagliflozin 50 milligrams (mg) or 150 mg, and metformin 500 mg or 1000 mg. The recommended dosing is twice daily. The prescribing information for INVOKAMET® also contains a boxed warning for lactic acidosis, a rare, but serious complication that can occur due to metformin accumulation.1

“The available doses of INVOKAMET® allow physicians to tailor therapy for individual patient needs and offer an alternative for people living with type 2 diabetes who may be able to reduce the number of pills they take each day,” said Paul Burton, M.D., Ph.D., Vice President, Medical Affairs, Janssen. “This expansion marks an important milestone as we continue to study INVOKAMET® and INVOKANA®—the number-one prescribed SGLT2 inhibitor with more than 8 million prescriptions to date—for the treatment of type 2 diabetes.”

 

Of the approximately 29 million people who have diabetes in the United States, 90 to 95 percent of them have type 2 diabetes, which is chronic and affects the body's ability to metabolize sugar (glucose), and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin.

 

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1 INVOKAMET® (canagliflozin and metformin hydrochloride) tablets, for oral use. Prescribing information, updated 05/2016.  Janssen Pharmaceuticals, Inc., Titusville, NJ, 08560.

2 American Diabetes Association. Glycemic targets. Sec. 5. In Standards of Medical Care in Diabetes – 2016. Diabetes Care 2016;39(Suppl. 1):S39–S46.

3 Garber AJ, Abrahamson MJ, Barzilay JI, et al. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM – 2016 EXECUTIVE SUMMARY. Endocr Pract. 2016 Jan;22(1):84-113.

4 American Diabetes Association. Approaches to glycemic treatment. Sec. 7. In Standards of Medical Care in Diabetesd2016. Diabetes Care 2016;39(Suppl. 1):S52–S59

5 Rosenstock J, Chuck L, González-Ortiz M, Merton K, Craig J, Capuano G, Qiu R. Initial Combination Therapy With Canagliflozin Plus Metformin Versus Each Component as Monotherapy for Drug-Naïve Type 2 Diabetes. Diabetes Care. 2016 Mar;39(3):353-62.

 

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