Tags: FDA | AstraZeneca | Bristol | Diabetes | Pill | Risks

FDA: AstraZeneca, Bristol Diabetes Pill Has Risks

Friday, 15 Jul 2011 02:40 PM

U.S. drug reviewers said a new pill from Bristol-Myers Squibb Co. and AstraZeneca PLC was effective in treating diabetes, but raised serious liver and cancer risks.

The pill, with the chemical name dapagliflozin, could also be less effective if patients had kidney problems, reviewers from the Food and Drug Administration said in documents released Friday.

Some analysts still think the FDA's panel of outside experts will recommend the drug for approval on Tuesday. But analysts said the drug's problems for the liver could be the biggest obstacle to approval for sale in the United States.

Bristol-Myers shares were down 0.8 percent in morning New York Stock Exchange trading, while AstraZeneca dipped 0.1 percent. The Standard & Poor's pharmaceutical index fell 0.7 percent.

Dapagliflozin could be the first in a new class of diabetes drugs designed to block glucose from being absorbed into the bloodstream through the kidneys, allowing more sugar to be excreted with urine.

People with diabetes have inadequate blood sugar control, which can lead to heart disease and stroke, damage to the kidneys or nerves, and blindness.

However, FDA reviewers said the pill probably caused at least one person — and possibly two — to develop a potentially life-threatening liver injury. According to FDA guidelines, two confirmed cases of drug-induced liver injury mean the pill is probably linked to this problem.

"At the least, we expect a strong warning in the label for the possibility of liver injury, and we also think there could be a requirement for liver function monitoring," said ISI Group analyst Mark Schoenebaum.

"This could reduce the competitiveness of (the drug) in the real world."

Schoenebaum earlier said a rejection of the drug would cut Bristol-Myers' 2015 earnings by 3 percent to 6 percent.

On average, analysts have forecast dapagliflozin's annual sales at $631 million by 2015, according to Thomson Pharma.

In clinical trials, the drug has been linked to a higher number of bladder and breast cancer.

However, the FDA said in the documents that the trials did not determine whether less than 10 patients with cancer were statistically significant, out of more than 5,000 taking the experimental drug. They asked the advisory panel to consider the issue next week.

The reviewers also mentioned some smaller potential issues with bone safety, and the long-term effects of urinary and genital infections.

Dapagliflozin leads to more sugar in the urine, which may serve as a nutrient for bacteria and pathogens that can cause infections, Bristol-Myers said earlier.

© 2017 Thomson/Reuters. All rights reserved.

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U.S. drug reviewers said a new pill from Bristol-Myers Squibb Co.and AstraZeneca PLCwas effective in treating diabetes, but raised serious liver and cancer risks. The pill, with the chemical name dapagliflozin, could also be less effective if patients had kidney problems,...
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