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UPDATE 2-US advisers against anemia drug restrictions

Tue Sep 11, 2007 6:21pm EDT
 
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(Recasts with panel vote, adds quotes, stock reaction)

By Kim Dixon and Lisa Richwine

GAITHERSBURG, Md Sept 11 (Reuters) - A U.S. panel of health experts gave Amgen Inc (AMGN.O: Quote, Profile, Research, Stock Buzz) and Johnson & Johnson (JNJ.N: Quote, Profile, Research, Stock Buzz) a win on Tuesday when they declined to recommend restrictions on the use of their anti-anemia drugs in kidney disease patients.

The news sent shares in Amgen, which reaps about half of its annual sales from anti-anemia drugs, sharply higher.

The Food and Drug Administration advisers voted 14-5 against setting an upper target for boosting oxygen-carrying hemoglobin for Amgen's Aranesp and Epogen, and Johnson & Johnson's Procrit, in patients with chronic kidney failure.

The meeting comes amid several studies suggesting high doses of the drugs lead to increased risk of heart problems and even death.

Sales of the three drugs, also given to cancer patients, topped $10 billion last year but have fallen in recent months amid safety concerns for their use in both patient groups.

The FDA usually takes the advice of its expert panels and officials said after the meeting it would make a decision about changes to the drugs' labels within weeks.

The agency asked the panel whether the labels on the drugs -- man-made forms of a protein that boosts red blood cell production -- should specifically target an oxygen-carrying hemoglobin level in the blood.  Continued...

 

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