RARITAN, N.J. — Janssen Pharmaceuticals Inc. has received approval from the Food and Drug Administration for Invokamet XR, a type 2 diabetes medication.

The Johnson & Johnson subsidiary said Invokamet XR, a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release, is indicated for first-line use as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes.

Invokamet XR combines Invokana (canagliflozin), the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor, with more than 9 million U.S. prescriptions since its launch, with 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,” according to John Anderson, M.D., of the Frist Clinic in 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.”

Janssen said Phase 3 studies have shown that 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 showed greater reductions in the secondary endpoints of body weight and systolic blood pressure, the company added.

“The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes,” stated Paul Burton, M.D., vice president of medical affairs at 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 comes in four dosages, in tablets containing canagliflozin 50 milligrams (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.

Invokamet, the first combination of an SGLT2 inhibitor and an immediate-release formulation of metformin available in the United States, was initially approved by FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes not adequately controlled with metformin or canagliflozin, or who were already being treated with both medications separately. In May 2016, the FDA expanded the Invokamet indication to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.

Of the roughly 29 million people in the U.S. who have diabetes, 90% to 95% have type 2 diabetes, which is chronic, 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, Janssen reported.