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news.Janssen Research & Development has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for extended release formulation of Invokamet XR to treat type 2 diabetes.
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Invokamet XR is a once-daily fixed-dose combination of canagliflozin and metformin hydrochloride extended release (XR) in two tablets for glycemic control in type 2 diabetics.
The FDA approved Invokamet in August 2014 as a fixed-dose combination tablet featuring canagliflozin and immediate release metformin hydrochloride.
The European Commission approved it in April 2014 under the name Vokanamet to treat adults with type 2 diabetes mellitus for improving glycemic control.
The FDA approved single agent canagliflozin, branded as Invokana, in March 2013.
Canagliflozin is currently being studied in various ongoing clinical trials, including in combination with metformin.
Two studies assessing Invokana and metformin versus standard treatments plus metformin demonstrated that the combination therapy with Invokana offered greater A1C and weight reduction than either comparator.
Janssen is also evaluating the effects of canagliflozin on diabetic nephropathy progression, cardiovascular safety, and renal endpoints and cardiovascular events risk.
Janssen global therapeutic area head of cardiovascular and metabolism James List said: "This submission to the FDA is evidence of Janssen’s continued commitment to bringing forth new treatment options for people with type 2 diabetes.
"We look forward to working with the FDA to bring this combination therapy to adult patients with type 2 diabetes in need of new options."