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INVOKAMET XR Receives FDA Approval for Treatment of T2D in Adults

“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. 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.”
-John Anderson, M.D., Frist Clinic, Nashville, Tenn. 

The FDA has just recently approved a new combination treatment manufactured and tested by Janssen Pharmaceuticals, Inc. for adults with T2D. Specifically, the combination treatment of canagliflozin (INVOKANA) plus metformin hydrochloride extended-release is a first-line treatment to improve blood glucose control, in conjunction with diet and exercise. This dual treatment works primarily to reduce A1C levels as well as secondarily to reduce overall body weight and systolic blood pressure.

The medication is recommended for those who qualify for dual treatment measures, specifically those with A1C (a two to three-month collected average of blood glucose) levels either above 7.5%, or individuals who started with A1C levels below 7.5%, but who have not reached goal levels after multiple months on single therapy. It is recommended by the American Diabetes Association that adults with T2D possess A1C levels that remain around 7% or less, and INVOKAMET XR aims to help individuals reach this guideline.

Metformin works to improve the body’s insulin response and decrease glucose production in the liver. It is usually utilized as an initial treatment for those with T2D. Canagliflozin is a SGLT2 inhibitor (sodium glucose co-transporter 2), that works in the kidneys to expel sugar through urination. Together, the once daily, fixed-dose combo has been proven to reduce A1C levels more than metformin alone, or metformin along with several other common treatments, as well as meet secondary endpoints of decreased systolic blood pressure and body weight. These results were upheld across seven Phase 3 trials including nearly 6,000 individuals with T2D.

The medication comes in four different fixed dosages, and is the first of its kind in the US. It has not been approved for use in children under 18 years of age, nor for the treatment of Type 1 Diabetes or ketoacidosis. The medication has been tolerated well, with the most common negative side effects including genital yeast infections, changes in urination, and urinary tract infections on the canagliflozin side, and diarrhea, asthenia, indigestion, abdominal discomfort, nausea, vomiting, and flatulence on the metformin side. There is a risk of lactic acidosis, as well as hypoglycemia and dehydration, so any previous kidney, urination, or metabolic acidosis problems should be discussed with a doctor before trying the new INVOKAMET XR.

Overall, the dual treatment seems to be showing promise, and the new FDA approval paves the way for its continued distribution and use!