FDA Approves Janssen’s Invokana, the First in a New Class of Type 2 Diabetes Medication

The FDA has approved Janssen Pharmaceutical’s new type 2 diabetes treatment, Invokana (canagliflozin).  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.  According to the company, 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. Invokana was approved for treatment of adult type 2 diabetes patients.

 

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 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.