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FDA Panel Recommends Approval of Canagliflozin for Diabetes

If approved, drug would be first SGLT2 inhibitor available in U.S. (Jan. 10)

The Endocrinologic and Metabolic Drugs Advisory Committee of the FDA has voted 10/5 to recommend the approval of canagliflozin (Janssen) for the treatment of type 2 diabetes in adults. The drug’s proposed trade name is Invokana.

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 with 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 kidneys, thereby increasing glucose excretion and lowering blood glucose levels in people with diabetes who have elevated blood glucose levels.

Data presented at the advisory committee meeting included results from the drug’s phase III clinical program, which enrolled 10,285 patients in nine studies. Canagliflozin was evaluated at once-daily doses of 100 mg and 300 mg in placebo- and active comparator-controlled studies, as well as in three large studies in special populations, i.e., older patients, patients with moderate renal impairment, and patients who had or were at risk for cardiovascular disease. The results showed that, in addition to improvements in glycemic control, both doses of canagliflozin were associated with weight loss and reductions in blood pressure across clinical studies.

The FDA will consider the advisory committee’s recommendation in its review of the new drug application (NDA) for canagliflozin, which was submitted on May 31, 2012.

Source: Johnson & Johnson; January 10, 2013.

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