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U.S. FDA Approves INVOKANA™ (Canagliflozin) For The Treatment Of Adults With Type 2 Diabetes

RARITAN, N.J., March 29, 2013 /PRNewswire/ -- Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) has approved INVOKANA™ (canagliflozin) for the treatment of adults with type 2 diabetes. INVOKANA™ is the first in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials.

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"Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life-threatening complications," said Richard Aguilar*, M.D., Medical Director, Diabetes Nation, LLC and Diabetes Care Foundation, a non-profit organization committed to improving diabetes care. "INVOKANA™ is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a 'glucuretic,' increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes – glucose in the urine – may also reflect the efficacy of a new and unique approach to treatment."

The kidneys make an important contribution to balancing blood glucose. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream.  An important carrier responsible for this reabsorption is called sodium glucose co-transporter 2 (SGLT2). INVOKANA™ selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes.  

"INVOKANA™ provides patients with type 2 diabetes the option of a once-daily oral therapy that offers improved glycemic control and, in Phase 3 studies, showed an incidence of hypoglycemia – low blood glucose – that was lower than with glimepiride and similar to that of sitagliptin," said Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals, Inc. "In addition, this new treatment option is associated with reductions in body weight and systolic blood pressure."

INVOKANA™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. INVOKANA™ has been studied as a single agent (monotherapy), in combination with metformin, and in combination with other glucose-lowering agents, including insulin, in patients who need further glucose control. Results from the Phase 3 studies showed INVOKANA™ was generally well tolerated. The most common adverse events with INVOKANA™ are genital mycotic (fungal) infections, urinary tract infections, and increased urination. These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in Phase 3 studies. Overall the rate of discontinuation due to adverse events was 4.3 percent for the INVOKANA™ starting dose of 100 milligrams (mg), 3.6 percent for INVOKANA™ 300 mg and 3.1 percent versus competitors. 

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