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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on September 11, 2007, 12:18:29 PM
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Amgen defends anemia drugs before U.S. panel
By Lisa RichwineTue Sep 11, 12:03 PM ET
Drugs that treat anemia caused by kidney failure provide important benefits despite the risks for some patients at high doses, Amgen Inc. told a U.S. advisory panel on Tuesday.
A group of outside experts that advises the Food and Drug Administration was reviewing use of Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit in patients with chronic kidney failure.
Sales of the three drugs, also given to cancer patients, topped $10 billion last year but have fallen in recent months amid safety concerns.
Studies found more deaths, heart attacks, strokes, heart failure and blood clots when high doses were given to kidney failure patients.
Amgen representatives said there were serious risks for patients when their hemoglobin levels were driven too high.
But when used appropriately, the drugs can allow patients to avoid blood transfusions to correct anemia, a common side effect of kidney failure, Amgen said.
The medicines provide "a clear reduction in burden and risk of transfusions. This is unquestioned," Dr. Preston Klassen of Amgen's global development division, told the panel.
J&J unit Ortho Biotech also said in a statement that Procrit provided "clear clinical benefit."
The FDA is asking the advisory panel if doctors should be instructed to boost a patient's hemoglobin to a specific range, among other things.
"We believe the safety concerns ... necessitate that we optimize the dosing information in the product label now," said Dr. Dwaine Rieves, acting director of the FDA's division of medical imaging and hematology products.
Any changes to the drugs' labels could influence how doctors prescribe them and how the U.S. Medicare insurance program pays for them, analysts say. The FDA usually follows panel recommendations.
A "black box" warning requested by the FDA in March advises doctors to give the lowest doses needed to avoid blood transfusions. It also warns about the risk of death and serious cardiovascular problems if hemoglobin tops 12 grams per deciliter. Hemoglobin is an oxygen-carrying protein in blood.
The anemia drugs are members of a family called erythropoiesis-stimulating agents, also known as ESAs or Epo drugs. The medicines are man-made forms of a natural protein that increases production of red blood cells.
A different FDA advisory panel that met in May urged limits on the drugs' use in cancer patients and more study of risks.
Medicare, which covers 43 million elderly and disabled Americans, has sharply cut payments for Epo drugs.
Aranesp and Epogen had combined 2006 sales of $6.6 billion, nearly half of Amgen's total sales for the year. Procrit is less important to J&J, a health-care products conglomerate.
http://news.yahoo.com/s/nm/20070911/hl_nm/anemia_drugs_dc_1