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Sunday, November 27, 2011

FDA Delays Ruling On Diabetic Medication Dapagliflozin.

The AP Share to FacebookShare to Twitter (10/27) reports Bristol-Myers Squibb Co. and AstraZeneca PLC announced Wednesday that the FDA "will take three more months to review an experimental diabetes pill" called dapagliflozin, "delaying a decision on the drug to late January." The experimental drug is a "once-per-day pill that is designed to help diabetes patients eliminate excess sugar through their urine," intended to treat "type 2 diabetes."
        Bloomberg News Share to FacebookShare to Twitter (10/27, Peterson) reports, "Outside advisers to the agency said in July that the effectiveness of the drug from New York-based Bristol-Myers and London-based AstraZeneca doesn't outweigh risks of bladder and breast cancer." This new medication "would be the first in a new class of treatments called SGLT2-inhibitors." The FDA said that it is "effective in reducing blood sugar" but the agency is focusing "on safety concerns in a preliminary review of the drug on July 15," which also includes "possible liver risks." The FDA "found that the drug's effectiveness waned in patients with moderate or severe kidney impairment." Also covering the story is Reuters Share to FacebookShare to Twitter (10/27).

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