U.S. FDA Approves INVOKANA™ (Canagliflozin) For The Treatment Of Adults With Type 2 Diabetes
INVOKANA™ is an important addition to the comprehensive platform of offerings for patients with diabetes from the Johnson & Johnson Family of Companies. Janssen will partner with other Johnson & Johnson companies focused on diabetes, such as LifeScan, Inc., and Animas Corporation, to bring INVOKANA™ to healthcare professionals treating patients with diabetes.
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.
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