Janssen also will offer a dedicated INVOKANA™ CarePath support program to patients and caregivers. The program provides important support and information regarding affordable access, adherence and education, thereby helping patients to start and appropriately manage their disease and therapy over time.
"We are delighted with the approval of INVOKANA™ because it provides a much-needed, new treatment option to help adults with type 2 diabetes and their physicians manage this disease," said Kirk Ways, M.D., Ph.D., Development Head, Cardiovascular & Metabolism and Compound Development Team Leader, Canagliflozin, Janssen Research & Development.
The new drug application for INVOKANA™ was based on a comprehensive global Phase 3 clinical program, which enrolled 10,285 patients in nine studies and is one of the largest clinical programs in type 2 diabetes submitted to health authorities to date.
Results from this program showed that the 100 mg and the 300 mg doses of INVOKANA™ improved glycemic control and, in prespecified secondary endpoints, were associated with significant reductions in body weight and systolic blood pressure. In two studies comparing INVOKANA™ to current standard treatments – one studying sitagliptin and the other studying glimepiride – INVOKANA™ dosed at 300 mg provided greater reductions in A1C levels and body weight than either comparator. A1C is the percent of red blood cell hemoglobin with glucose attached to it and an indicator of average blood glucose over the previous two to three months. In the two studies, the overall incidence of adverse events was similar with INVOKANA™ and the comparators.
In studies of INVOKANA™ as monotherapy or in combination with agents not associated with hypoglycemia (such as metformin or metformin and pioglitazone), the incidence of hypoglycemic episodes were less than 5 percent across the groups (INVOKANA™ 100 mg [3.8 percent], INVOKANA™ 300 mg [4.3 percent], and placebo [2.2 percent]). There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with INVOKANA™ or any other antidiabetic medication. Additional data are being collected to further characterize the cardiovascular profile of INVOKANA™.
The Phase 3 studies for INVOKANA™ were presented at the American Diabetes Association (ADA) Annual Scientific Sessions in June 2012, at the European Association for the Study of Diabetes (EASD) Annual Meeting in October 2012, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in November 2012.
Janssen and its affiliates have rights to INVOKANA™ 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.
About Type 2 Diabetes
The U.S. Centers for Disease Control and Prevention estimates that nearly 26 million Americans have diabetes, 90 to 95 percent of which is type 2 diabetes. 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.1 U.S. national data from 2007 to 2010 show that nearly half of adults with type 2 diabetes were not achieving recommended levels of glucose control.2
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