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news.Janssen Pharmaceuticals has secured approval from the US Food and Drug Administration (FDA) for a fixed-dose combination therapy to treat adults with type 2 diabetes.
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The drug, dubbed Invokamet XR, is a combination of canagliflozin, a sodium glucose cotransporter 2 inhibitor found in Janssen’s Invokana, and an XR formulation of metformin, a commonly prescribed therapy for type 2 diabetes.
The treatment has been approved for first-line use as an adjunct to diet and exercise to enhance blood glucose control in adults with type 2 diabetes when treatment with the two medications is appropriate.
The FDA approved Invokamet in August 2014 as an adjunct to diet and exercise to enhance glycemic control in adults with type 2 diabetes not adequately controlled with metformin or canagliflozin, or who are already being treated with both medications separately.
In May this year, the regulator 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.
Phase 3 studies have demonstrated 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 showed greater reductions in the secondary endpoints of body weight and systolic blood pressure.
Invokamet XR is available in four dosages, in tablets featuring canagliflozin 50 mg or 150 mg, and metformin XR 500 mg or 1000 mg.
Janssen medical affairs vice president Paul Burton said: “The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes.
“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.”