Johnson & Johnson Press Release (05/31/12)
Janssen Research & Development is asking the U.S. Food and Drug Administration to approve the use of the selective sodium glucose co-transporter 2 (SGLT2) inhibitor canagliflozin for the treatment of adults with diabetes. The oral, once-daily drug would specifically be used to prevent the kidneys of people with type 2 diabetes from reabsorbing glucose, which in turn would result in increased glucose excretion and lower blood glucose levels. The kidneys of type 2 diabetics tend to reabsorb more glucose back into the body than do the kidneys of non-diabetics. Janssen Research & Development's application to the FDA is being supported by a comprehensive global Phase 3 clinical development program, in which roughly 10,300 patients participated in nine multi-center, randomized clinical studies. Those studies looked at the safety and effectiveness of using canagliflozin across the spectrum of type 2 diabetes. The results of those studies, which also included placebo- and active comparator-controlled studies, will be presented at the Scientific Sessions of the American Diabetes Association in Philadelphia in June, as well as other scientific venues.