FDA sets panel review of Glaxo clotting drug-Amgen

Wed May 7, 2008 9:21pm EDT
 
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LOS ANGELES, May 7 (Reuters) - A panel of expert advisers to the U.S. Food and Drug Administration will meet at the end of this month to review GlaxoSmithKline Plc's (GSK.L: Quote, Profile, Research, Stock Buzz) experimental drug for treating a disorder in which the blood does not clot properly, according to Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz).

Both Amgen and Glaxo are seeking FDA approval for medicines for chronic immune thrombocytopenic purpura (ITP), a condition in which a low count of platelets in the blood hampers clotting.

The FDA last month delayed a decision on Amgen's romiplastin to July 23 in order to review additional information cited by the company. A panel of FDA experts had unanimously voted in March to recommend approval of the Amgen drug.

Glaxo, which could not be reached for comment, said in March the FDA had granted priority review of its drug, Promacta.

The FDA advisory committee meeting will be held on May 30 in Chicago during the annual meeting of the American Society for Clinical Oncology, Amgen spokeswoman Christine Regan said.

An FDA spokeswoman said she was unable to comment on panel meeting schedules until they are published in the Federal Register. (Reporting by Deena Beasley; Editing by Braden Reddall)

 

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