Diabetes Drug Approved by U.S. FDA Committee
A U.S. Food and Drug Administration (FDA) committee this week approved the drug canagliflozin for the treatment of adults with type 2 diabetes. The Endrocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 10 to 5 to approve the drug.
Canagliflozin, which Johnson & Johnson has given the proposed trade name of Invokana, will, if further approved by the FDA later this year, be the first of a new type of diabetes drugs to be available in the U.S. It is a selective glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidneys, which increases glucose excretion and lowers blood glucose levels. People with type 2 diabetes have kidneys that reabsorb greater-than-normal amounts of glucose back into the body.
“We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the U.S. to help them manage their type 2 diabetes,” said Dr. Peter Stein, head of the Metabolism Development and Diabetes Disease Area departments at Janssen Research & Development, the Johnson & Johnson R&D company that developed the drug. “Today’s outcome represents an important step toward achieving that goal.”
The approval came after the results of a phase 3 clinical trial were presented at diabetes conferences last year. According to Janssen, the trial, which looked at 10,285 patients, was the “largest late-stage development program for an investigational pharmacologic product for the treatment of type 2 diabetes” ever submitted to health authorities. The results showed that canagliflozin improved glycemic control and was associated with weight loss and lower blood pressure. The side effects of the drug included yeast infections and urinary tract infections.