Friday, 11 January 2013

Against diabetes drug approved by the FDA Committee

U.S. Food and Drug Administration (FDA) approved the committee this week canagliflozin drug for the treatment of adults with type 2 diabetes. The Committee Endrocrinologic and metabolic FDA Advisory voted 10-5 to approve the drug.


Canagliflozin, Johnson & Johnson, who gave the proposed trade name of Invokana will, if also approved by the FDA later this year, the first of a new type of drugs against diabetes 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 the excretion of glucose and lowers blood glucose Blood. People with type 2 diabetes who have kidney reabsorb greater than normal amounts of glucose in the body.


“We are pleased with the positive recommendation of the committee and look forward to working with the FDA to bring this important new treatment for patients in the United States to help them manage their type 2 diabetes,” said Dr. Peter Stein, head of development of diabetes and metabolic disease departments in the region of Janssen Research & Development, Johnson & Johnson R & D has developed the drug. “As a result of today represents an important step towards achieving this goal.”


approval comes after the results of a phase 3 clinical trial were presented at conferences diabetes the last year. According to Janssen, the trial, which involved 10,285 patients, was “the largest program of advanced development for an experimental pharmacological treatment of type 2 diabetes” never submitted to the health authorities. The results showed that canagliflozin improved glycemic control and was associated with weight loss and blood pressure. Side effects of the drug include yeast infections and urinary tract infections.

reports webpronews.com

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