Monday, May 7, 2012

Reuters: Regulatory News: FDA staff question Pfizer arthritis drug benefits

Reuters: Regulatory News
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FDA staff question Pfizer arthritis drug benefits
May 7th 2012, 12:36

WASHINGTON | Mon May 7, 2012 8:36am EDT

WASHINGTON May 7 (Reuters) - U.S. drug reviewers questioned whether the benefits of Pfizer Inc's experimental treatment for rheumatoid arthritis outweighed its risks of cancerous cells and infections.

The Food and Drug Administration staff said the drug, called tofacitinib, appeared to reduce swollen and tender joints during clinical trials, but questioned the method of using radiographs to prove the drug worked.

The FDA staff review comes ahead of an advisory panel, which will vote on whether to recommend the drug on Wednesday. The FDA will make a final decision in August, taking into account the panel's recommendations.

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