RARITAN, N.J., March 29, 2013 – 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 cotransporter 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.
“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.
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 pre-specified 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™.
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
Approximately 60 percent of patients with type 2 diabetes in the United States are obese, while another 30 percent are overweight. In most people at risk for type 2 diabetes, obesity causes the body to resist the action of insulin, and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue. If left uncontrolled, type 2 diabetes can lead to serious complications; improved glycemic control has been demonstrated to reduce the onset and progression of these complications.1
1 Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011. Available at: http://www.diabetes.org/in-mycommunity/local-offices/miami-florida/assets/files/national-diabetes-fact-sheet.pdf. Accessed January 28, 2013.
2 Casagrande SS, Fradkin JE, Saydah SH, Rust KF, Cowie CC. The prevalence of meeting A1C, blood pressure, and LDL goals among people with diabetes, 1988–2010. Diabetes Care. 2013 Feb 15. Epub ahead of print.