Janssen Submits NDA for Canagliflozin
The filing is supported by a comprehensive global Phase 3 clinical development program.
Janssen Research & Development, LLC has submitted a New Drug Application (NDA) to the U.S. 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 kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. Canagliflozin blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
The filing is supported by a comprehensive global Phase 3 clinical development program, which included nine multicenter, randomized clinical studie
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