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FDA Panel Recommends Bristol, AstraZeneca Diabetes Drug

Update Date: Dec 13, 2013 11:20 AM EST
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The U.S. Food and Drug Administration's (FDA) panel of medical experts has finally backed a new type of diabetes drug. The drug, which is created by Bristol-Myers Squibb and AstraZeneca, was previously rejected by the agency two years ago due to concerns over the safety of the drug. Now, the FDA's advisory panel voted 13 to one in favor of dapagliflozin stating that the drug could benefit people more than it could harm.

In January 2012, the FDA had rejected the drug due to concerns over the risks involved with cancer and cardiovascular health. At the time, the medical advisory panel found insufficient evidence that the drug was safe enough to use. Now, the panel has voted 10 to four stating that dapagliflozin is safe for the heart.

Although the FDA has not approved dapagliflozin, the agency often follows the recommendations of its advisory panel. The drug is currently approved and sold as Forxiga in Europe. This class of drugs works by blocking a protein called SGLT2. This protein is responsible for lowering blood sugar independently of insulin. The drug blocks the kidneys from reabsorbing the blood sugar, which then leads to the removal of glucose though the urine.

Despite the approval by the panel, during discussion, the members were concerned about the potential risk of bladder cancer. In one of the large trials, 10 patients who were on this drug went on to develop bladder cancer. The experts believe that at least six of the patients' cases were not related to the drug because the cancer had manifested within months after treatment started. The experts reasoned that the drug would cause cancer to develop in years and not months.

"I really like this drug," commented panel member, Dr. Milton Packer, a cardiologist and chairman of clinical sciences with the University of Texas Southwestern Medical Center located in Dallas reported by Reuters. However, Packer stated that monitoring bladder cancer risk is important.

The drug-manufacturing companies now await the FDA's decision.

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