Amgen Wins Panel Backing for Aranesp Before Dialysis
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Amgen Inc.’s anemia treatment Aranesp is safe for use in kidney patients whose disease doesn’t require dialysis, a U.S. panel found.
Outside advisers to the Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a “rescue therapy” after a doubling of stroke risk was seen in a study of 4,000 patients with mild to moderate kidney disease.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.