FDA Puts New Restrictions on Amgen’s Aranesp

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Aranesp, biotech giant Amgen Inc.’s once-highflying anemia drug, took another hit Wednesday when the Food and Drug Administration ordered new restrictions on the way physicians prescribe it to cancer patients.


Amgen’s most successful biotech franchise, Aranesp has been under review by U.S. health officials since it was tied to a greater risk of heart attack, stroke and death at high doses in cancer patients nearly two years ago. Anemia is a common side effect from chemotherapy.


The new restrictions also apply to Procrit, an identical product made by Amgen and sold by Johnson & Johnson.


Industry analysts said the news was largely expected and cited a significant reduction in anemia drug sales in the last year. Shares of the Thousand Oaks-based company gained 2 cents to close at $62.30 on Wednesday.


The news came less than a week after Amgen announced that its experimental osteoporosis drug denosumab reduced fractures in a study of women with the bone-thinning disease, causing Amgen’s stock to jump 13% on Monday.


Amgen said it would begin communicating the revised product labeling for the drugs to physicians and patients.





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