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Janssen seeks FDA approval for canagliflozin as Type 2 diabetes treatment


RARITAN, N.J. — A Johnson & Johnson subsidiary is seeking approval for a Type 2 diabetes treatment.

Janssen Research and Development has submitted a new drug application to the Food and Drug Administration for the approval of canagliflozin — an investigational oral, once-daily, selective sodium glucose co-transporter 2 inhibitor — for use in adult patients. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels, the company said.

The filing was supported by a comprehensive global phase-3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients. The late-stage clinical trial evaluated the safety and efficacy of canagliflozin across the spectrum of Type 2 diabetes and included placebo- and active comparator-controlled studies. The program also included a dedicated cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma. Janssen Pharmaceuticals has marketing rights in North America, South America, Europe, Middle East, Africa, Australia, New Zealand and parts of Asia.

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