Amgen Inc.’s anemia treatment Aranesp is safe for use in kidney patients whose disease doesn’t require dialysis, a U.S. panel said Monday.
Outside advisers to the Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a “rescue therapy” after a doubling of stroke risk was seen in a study of 4,000 patients with mild to moderate kidney disease. The panel recommended more studies to better explain which patients benefit from Aranesp and what dosing is ideal.
Aranesp sales have fallen by a third since 2006 over safety concerns, and doctors have curbed use in kidney patients since the stroke risks were reported last year.
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