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FDA approves fixed-dose combination canagliflozin, metformin extended release
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The FDA has approved a once-daily, fixed-dose combination therapy of the SGLT2 inhibitor canagliflozin and extended-release metformin for first-line use to treat type 2 diabetes, Janssen announced in a press release.
The first fixed-dose combination of canagliflozin and metformin (Invokana, Janssen) was initially approved by FDA in August 2014 as an adjunct to diet and exercise to improve glycemic control in adults who have type 2 diabetes not adequately controlled with metformin or canagliflozin alone, or who are already being treated with both medications separately. In May 2016, the FDA expanded the drug’s indication to include adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy.
“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 HbA1c levels,” John Anderson, MD, of Frist Clinic, Nashville, Tennessee, said in a press release. “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 HbA1c levels are not well controlled with either agent alone.”
Invokamet XR is available in four dosages: tablets containing 50 mg or 150 mg canagliflozin, and 500 mg or 1,000 mg metformin XR. The recommended dosing is two tablets once daily with the morning meal.
The prescribing information for fixed-dose canagliflozin and metformin XR also contains a Boxed Warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation. The drug should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
“The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes,” Paul Burton, MD, PhD, vice president of medical affairs, Janssen, said in the statement. “Our Invokana portfolio now offers physicians even more choices for helping patients improve control of HbA1c levels and other important health measures, with numerous dosing options for monotherapy and for combination therapy with both metformin and metformin XR.”