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FDA OKs Aranesp for pre-dialysis patients

By   /   Monday, October 25th, 2010  /   Comments Off on FDA OKs Aranesp for pre-dialysis patients

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Amgen’s anemia treatment Aranesp is safe for kidney patients whose disease doesn’t require dialysis, a federal panel announced Oct. 18 in response to a study that found the drug could increase stroke risk in those patients.

Outside advisers to the U.S. Food and Drug Administration said the treatment shouldn’t be withdrawn or limited to a “rescue therapy” because of the recent study, Bloomberg News reported.

Aranesp accounts for 18 percent of revenue at Thousand Oaks-based Amgen. Eliminating pre-dialysis use may shave $200 million to $400 million from annual sales, or 5 to 10 cents from per-share earnings, an analyst told Bloomberg.

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