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Merck’s Proscar Fails to Win U.S. FDA Panel’s Backing

Merck & Co.’s enlarged-prostate treatment Proscar failed to win the support of a U.S. advisory panel for use in preventing prostate cancer.

Outside advisers to the Food and Drug Administration voted 17-0 with one abstention today that Proscar has an unfavorable balance of risks and benefits in healthy men at least 55 years old. Merck, based in Whitehouse Station, New Jersey, asked to add data from its studies in prostate cancer to the prescribing information for Proscar, approved in 1992.

“Merck continues to believe that incorporating more comprehensive and relevant clinical data” from the Proscar study in prostate cancer prevention “is important in ensuring health-care professionals and patients have access to all the information available to make informed treatment decisions,” the company said today in an e-mail after the vote.

The FDA panel, by a 14-2 vote, also declined to back GlaxoSmithKline Plc’s application for formal approval to expand use of its similar medicine Avodart in men at risk for prostate cancer.

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