A panel of advisers to U.S. health regulators voted on Tuesday to reject new restrictions on anemia drugs, a win for drugmakers Amgen and Johnson & Johnson.
Ric Francis
The sign outside Amgen Inc.'s entrance. Thousand Oaks, Calif.
The advisers to the Food and Drug Administration voted against setting a new limit for targeted hemoglobin of 11 grams per deciliter for Amgen's Aranesp and Epogen and Johnson & Johnson's Procrit in patients with chronic kidney failure who are on dialysis.
The advisory meeting comes amid concerns that high doses of the drug lead to increased risk of heart problems and even death.
Any changes to the drugs' labels could have influenced how doctors prescribe them and how the U.S. Medicare insurance program pays for them, analysts say. The FDA usually follows
panel recommendations.
Amgen told the panel earlier that the drugs that treat anemia caused by kidney failure provide important benefits despite the risks for some patients at high doses.
Sales of the three drugs, also given to cancer patients, topped $10 billion last year but have fallen in recent months amid safety concerns.
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.
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."
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.
A different FDA advisory panel that met in May urged limits on the drugs' use in cancer patients and more study of risks.
