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.

"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 US to help them manage their type 2 diabetes," said Peter Stein, MD, head, Metabolism Development, Diabetes Disease Area Leader, Janssen. "Today's outcome represents an important step toward achieving that goal."

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.

Janssen presented data from phase III studies at the American Diabetes Association (ADA) in Philadelphia in June, at the European Association for the Study of Diabetes (EASD) in Berlin in October, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in Barcelona in November.

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.

Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand, and parts of Asia.

Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. In most people with type 2 diabetes, obesity causes resistance of the body to the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycaemia and type 2 diabetes ensue.

If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular complications such as nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications. About half of patients with type 2 diabetes do not achieve levels of glucose control recommended by their doctor.

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