UPDATE 2-US FDA orders Amgen to add new anemia drug warning
(New throughout; adds reaction, analyst comment, detail, background)
WASHINGTON, July 30 (Reuters) - U.S. health officials ordered Amgen Inc (AMGN.O) on Wednesday to add new warnings to its widely used anemia drug Aranesp and similar medicines about the serious risks to cancer patients.
Eight studies have found evidence of tumor growth or shorter survival for some patients given high doses of the drugs, which also include Procrit, sold by Johnson & Johnson (JNJ.N) under a license from Amgen.
A strong, "black box" warning now must say the drugs are not indicated for patients undergoing chemotherapy expected to cure their cancer, the Food and Drug Administration said.
Amgen said in a statement the label changes were consistent with the company's expectations and the potential impact was factored into its earnings guidance issued on Monday.
The FDA said it negotiated the changes with Amgen but was unable to reach agreement on the wording of two points. 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 drug labels.
Tens of thousands of cancer patients take Aranesp and Procrit for anemia caused by chemotherapy. Anemia, or low levels of red blood cells, causes fatigue and weakness.
The drugs have not been shown to improve cancer patients' quality of life, said Dr. Richard Pazdur, head of the FDA office that reviews cancer drugs.
"We really think patients should think once, think twice and think a third time whether they should be receiving these drugs," Pazdur said by telephone.
Sales of Aranesp, one of Amgen's top-selling products, have fallen sharply since the FDA announced in March 2007 the drugs would carry a warning about death and life-threatening side effects seen in studies. Wednesday's action updated that warning.
The changes announced Wednesday were "in line to maybe better" than expected, Cowen & Co analyst Eric Schmidt said. "Probably the most important thing here is that it is now officially, officially behind us."
The new prescribing instructions say patients should not begin treatment with the drugs if their hemoglobin levels are greater than, or equal to, 10 grams per deciliter.
Doctors are directed not to give the drugs when hemoglobin exceeds the level that avoids a blood transfusion, the FDA said.
Amgen objected to language warning against use in cancer patients who may be cured by chemotherapy and dosing instructions for hemoglobin levels, Pazdur said.
Total Aranesp sales fell 12 percent last year to $3.6 billion. About $1.5 billion were U.S. cancer-related sales. Procrit sales slid 9 percent to $2.9 billion. The drugs also are sold for kidney disease patients.
Aranesp sales made a surprising increase in the second quarter of 2008 to $825 million, up from $761 million in the previous quarter.
But Schmidt projected a further decline of $300 million in annual Aranesp sales.
The FDA did not order warnings against giving the drugs to any patient with advanced breast cancer or head and neck cancer, despite a recommendation by an advisory panel in March. Other advice from the panel is largely reflected in the new label, FDA's Pazdur said.
Ortho Biotech, the Johnson & Johnson unit that sells Procrit, is reviewing the FDA action, spokeswoman Stephanie Fagan said.
The injectable drugs, known as erythropoiesis-stimulating agents (ESAs), are genetically engineered forms of a protein that boosts production of red blood cells. Amgen also markets another ESA drug called Epogen for kidney disease patients.
Amgen shares gained 2 cents to close at $62.30 on Nasdaq. Shares of Johnson & Johnson fell 40 cents to close at $68.08 on the New York Stock Exchange. (Reporting by Lisa Richwine, Susan Heavey and Deena Beasley; Editing by Tim Dobbyn and Andre Grenon)
