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Amgen’s, J&J’s Anemia Drugs Face FDA Advisory Review on Dose

Amgen Inc. and Johnson & Johnson face a review of their top-selling anemia drugs by an advisory panel for the U.S. Food and Drug Administration.

The FDA will ask its advisers to evaluate whether lower doses would avoid increased risks of blood clots and heart attacks in patients with chronic kidney disease. The panel was announced in a New England Journal of Medicine commentary.


Amgen’s Aranesp and Epogen and Johnson & Johnson’s Procrit are known as erythropoiesis-stimulating agents, or ESAs, and are used to boost levels of hemoglobin, an element of red blood cells.

“Randomized trials have endeavored to show that using ESAs to raise hemoglobin concentration to higher targets improves clinical outcomes,” Robert Temple, deputy director for clinical science at the FDA’s Center for Drug Evaluation and Research, and his colleagues wrote in the commentary. “Unfortunately and unexpectedly, all results have suggested the opposite.”
Temple was referring to a series of studies suggesting that using high doses of the drugs to get hemoglobin to normal levels may increase the risk of heart attacks and strokes rather than lower it.

Aranesp was found to increase the risk of blood clots and strokes in patients with kidney disease and diabetes, according to an Oct. 30 study on anemia drugs, sponsored by Amgen and published in the New England Journal of Medicine.

Among the 4,000 patients in the study, 5 percent of those who took Aranesp had strokes, about double the rate of those who took placebos. The research also found that in patients with a history of cancer, 60 of 188 patients taking Aranesp died, compared with 37 of 160 on placebos.

“For many patients, the increased risk of stroke that was uncovered and possible deaths in those patients with prior malignancy outweigh the potential benefit” of the drug, Marc Pfeffer, a heart specialist at Brigham & Women’s Hospital in Boston who led the study, said at the time.

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