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Glaxo Denied Approval for Expanded Use of Avodart

GlaxoSmithKline Plc said it failed to win approval from U.S. regulators for expanded use of its enlarged-prostate therapy Avodart to treat the estimated 1 million American men at risk for prostate cancer.

Glaxo received a so-called complete response letter from the U.S. Food and Drug Administration rejecting the application to expand Avodart’s use, the London-based company said today in a statement. An FDA advisory panel voted 14-2 on Dec. 1 to recommend against the expanded use of the drug, deciding the risks that some patients will develop aggressive tumors, as seen in a study, outweighed its benefits.

Avodart is approved for men with benign prostate hyperplasia, or enlarged prostates, and had 2009 sales of $830 million, according to Bloomberg data. FDA approval was expected to add more than $1 billion to annual sales before safety risks emerged, according to Navid Malik, an analyst at Matrix Corporate Capital, in London.

Glaxo didn’t specify why the FDA rejected the application to expand Avodart’s use or whether it would apply again.

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