RARITAN, N.J., Jan. 10, 2013 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 10-5 to recommend approval for canagliflozin, proposed trade name INVOKANA™, to treat type 2 diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program.
Canagliflozin is an investigational, oral, once-daily medication for the treatment of adult patients with type 2 diabetes. If approved by the FDA later this year, it would be the first in this new class of diabetes therapies available in the U.S. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people who do not have diabetes, which may contribute to elevated glucose levels. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels.
"We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the U.S. to help them manage their type 2 diabetes," said Peter Stein, M.D., Head, Metabolism Development, Diabetes Disease Area Leader, Janssen. "Today's outcome represents an important step toward achieving that goal."
Data presented at today's advisory committee meeting included results from the comprehensive global Phase 3 clinical program, which enrolled 10,285 patients in nine studies; it is the largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes submitted to health authorities to date. Canagliflozin was evaluated at 100 mg and 300 mg once-daily doses in placebo- and active comparator-controlled studies, as well as three large studies in special populations: older patients, patients with moderate renal impairment, and patients who had or were at risk for cardiovascular disease. Results showed that in addition to the improvements in glycemic control, both doses of canagliflozin were associated with weight loss and reductions in blood pressure across clinical studies.