NDA Submitted for Canagliflozin for Type 2 Diabetes
Janssen Research & Development announced that it has submitted a New Drug Application (NDA) to the FDA seeking approval for the use of canagliflozin, an investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor, for the treatment of adult patients with type 2 diabetes.
The filing is supported by a comprehensive global Phase 3 clinical development program, which included nine multicenter, randomized clinical studies that enrolled approximately 10,300 patients, representing the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date. The Phase 3 program 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.
Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels. The kidneys of patients with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic patients, which may contribute to elevated glucose levels.
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