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US panel rejects anemia drug limit in non-dialysis

Tue Sep 11, 2007 4:33pm EDT

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GAITHERSBURG, Maryland, Sept 11 (Reuters) - Advisers to U.S. health regulators voted on Tuesday to reject a target hemoglobin level for kidney-disease patients not on dialysis, the second vote that favors drugmakers Amgen and Johnson and Johnson, which had urged a more liberal approach to treatment.

Regulatory News

The Food and Drug Administration advisers voted against setting a limit for targeted hemoglobin of 11 grams per deciliter for Amgen's (AMGN.O) Aranesp and Epogen and Johnson & Johnson's (JNJ.N) Procrit, for patients with chronic kidney failure who are not on dialysis.

Earlier, the panel voted against a strict target of about 11 for kidney disease patients on dialysis, the process of clearing waste from the blood in these patients.

The meeting comes amid concerns that high doses of the drugs lead to increased risk of heart problems and even death.

The FDA usually takes the advice of its expert panels. (Reporting by Kim Dixon)



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