Bloomberg News

Bristol Myers-AstraZeneca Diabetes Drug Delayed by U.S. FDA

October 26, 2011

(Updates with statement from company in fourth paragraph.)

Oct. 26 (Bloomberg) -- Bristol-Myers Squibb Co. and AstraZeneca Plc said U.S. regulators delayed a decision for three months on whether to approve the companies’ experimental diabetes pill.

The Food and Drug Administration postponed its decision on the drug, dapagliflozin, while asking the companies to submit data from recent completed and ongoing late-stage clinical trials, Bristol-Myers and AstraZeneca said today in a statement.

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. Diabetes pills have faced greater regulatory scrutiny since GlaxoSmithKline Plc’s top-selling Avandia was tied to heart attacks in 2007 and was ultimately forced off the market in Europe and restricted in the U.S.

“Bristol-Myers Squibb and AstraZeneca are committed to dapagliflozin as a potential new therapeutic option for adults with Type 2 diabetes,” Brian Daniels, Bristol Myers’s senior vice president of Global Development and Medical Affairs, said in the statement.

Bristol-Myers gained 1.3 percent to $32.51 at the close of New York trading before the companies’ announcement. AstraZeneca gained less than 1 percent to 3,041.5 pence in London.

Dapagliflozin may earn $308 million in sales for Bristol- Myers, and $144 million for AstraZeneca, in 2015, according to the average estimates of two analysts compiled by Bloomberg.

New Class

The drug would be the first in a new class of treatments called SGLT2-inhibitors that work by letting patients excrete excess blood sugar in their urine. Johnson & Johnson, Eli Lilly & Co., Boehringer Ingelheim GmbH, and Astellas Pharma Inc. are among companies pursuing similar drugs.

While FDA staff said dapagliflozin is effective in reducing blood sugar, they focused on safety concerns in a preliminary review of the drug on July 15.

Nine cases of bladder cancer occurred in male patients who took dapagliflozin in clinical trials, compared with one case among people treated with a placebo, FDA staff said in their report. Breast cancer occurred in nine patients who took the new drug, and one in the control group.

The agency reviewers also cited possible liver risks among dapagliflozin’s “unexpected safety issues,” and found that the drug’s effectiveness waned in patients with moderate or severe kidney impairment.

An estimated 25.8 million people in the U.S. have diabetes, mostly the Type 2 form tied to being overweight and sedentary, according to the National Institutes of Health. The disease is caused by an inability to use insulin to break down blood sugar into energy and can increase the risk of heart disease, stroke and kidney damage. Medicines are used to reduce blood sugar.

--Editor: Andrew Pollack

To contact the reporter on this story: Molly Peterson in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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