Johnson & Johnson (JNJ) company Janssen Pharmaceuticals, Inc. announced the U.S. FDA approval for INVOKANA or canagliflozin tablets for the treatment of 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.
According to the FDA, Type 2 diabetes is the most common form of the disease, affecting about 24 million people and accounting for more than 90 percent of diabetes cases diagnosed in the U.S.
"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research.
Janssen noted that the global Phase 3 clinical program, which enrolled 10,285 patients in nine studies, 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.
Invokana works by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels.
Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals, Inc., stated, "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,"
The FDA specified that the most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection.
Janssen plans to partner with other Johnson & Johnson companies focused on diabetes to bring the product to healthcare professionals treating patients with diabetes.
JNJ closed Thursday's regular trading session at $81.53.
by RTT Staff Writer
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