How does Invokana work?
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.
Invokana is an 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.
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.