The Endocrinologic and Metabolic Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted 10-5 to recommend approval for Janssen Research & Development's 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 programme.

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 US. 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.

Data presented at the advisory committee meeting included results from the comprehensive global phase III clinical programme, which enrolled 10,285 patients in nine studies; it is the largest late-stage development programme 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.

Canagliflozin was generally well tolerated. It has specific safety and tolerability issues that were well characterized in this development programme (such as the genital mycotic infections, urinary tract infections) and can be well managed by the physician, and for some of these issues by the patient.

The US FDA will consider the advisory committee recommendation in its review of the New Drug Application (NDA) for canagliflozin that was submitted by Janssen on May 31, 2012, though the FDA is not bound to follow it.

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