Bloomberg Anywhere Remote Login Bloomberg Terminal Demo Request


Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world.


Financial Products

Enterprise Products


Customer Support

  • Americas

    +1 212 318 2000

  • Europe, Middle East, & Africa

    +44 20 7330 7500

  • Asia Pacific

    +65 6212 1000


Industry Products

Media Services

Follow Us

Bloomberg Customers

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.

Please upgrade your Browser

Your browser is out-of-date. Please download one of these excellent browsers:

Chrome, Firefox, Safari, Opera or Internet Explorer.