FDA Orders Amgen To Change Label For Anemia Drug Aranesp, Similar Drugs

Jul 31, 2008 (financialwire.net via COMTEX) -- JNJ | Quote | Chart | News | PowerRating -- July 30, 2008 (FinancialWire) The Food and Drug Administration has ordered Amgen Inc. (NASDAQ: AMGN | Quote | Chart | News | PowerRating) to change the prescribing instructions for Aranesp and similar anemia drugs to address concerns about the risks to cancer patients.

The changes apply to Amgen's Aranesp and Procrit, which is sold by Johnson & Johnson (NYSE: JNJ | Quote | Chart | News | PowerRating) under a license from Amgen. The drugs are known as erythropoiesis-stimulating agents.

The FDA said that the labels for the drugs now must say they are not indicated for patients undergoing chemotherapy with the intention to cure the patient. The instructions also will say treatment with the drugs should not be started if patients' hemoglobin levels are greater than, or equal to, 10 grams per deciliter.

The FDA and Amgen reached agreement on all but two changes to the drug labels. The agency ordered Amgen to make all of the revisions, the first time it has invoked new powers granted last year to force companies to amend labels. Amgen markets another ESA drug called Epogen for kidney disease patients.

Amgen shares rose two cents to close at $62.30, while shares of Johnson & Johnson fell 40 cents to close at $68.08 Wednesday.

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