The filing is based on a global Phase III clinical development program, including nine multicenter, randomized clinical studies, which evaluated the safety and efficacy of canagliflozin across the spectrum of type 2 diabetes and included placebo- and active comparator-controlled studies.
A cardiovascular study conducted in patients who have or are at high risk for developing cardiovascular disease was also included in the program.
The investigational, oral, once-daily, selective sodium glucose co-transporter 2 (SGLT2) inhibitor will prevent the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
Janssen and its affiliates have rights to canagliflozin through a licensing contract with Mitsubishi Tanabe Pharma.