A European advisory committee is recommending stronger warnings be placed on the class of anemia drugs that includes Amgen Inc.'s Aranesp, as U.S. regulators have already done.
Even so, the recommendation by the European Medicines Agency panel still allows the drugs to be used when a patient's anemia is less severe than officials for the U.S. Centers for Medicare and Medicaid specified in a revised reimbursement policy issued in August, Thousand Oaks-based Amgen said late Thursday.
The Medicare standard, which would affect how much doctors would be reimbursed when prescribing Aranesp to cancer patients, has been strongly protested both by Amgen and physician associations, which patients would be put at greater risk for needing transfusions if they have to follow the Medicare guidelines.
Aranesp, which is approved to treat anemia associated with chemotherapy, has come under fire in the U.S. due to safety concerns. Sales of Aranesp and an older version, Epogen, accounted for nearly half of Amgen's sales in 2006.
The European committee's proposals are generally in line with what the U.S. Food and Drug Administration already has required as far as strengthening the drug's warning label. Patients are to be informed about studies indicating increased risk for heart complications and even death if higher than recommended doses are given. They also are reminded that drugs have not been shown to improve the overall survival rates in patients.
Approval of the final European regulations is expected in early 2008, Amgen said.
Shares in Amgen were up 18 cents to $56.26 in afternoon trading Thursday. Shares in Amgen have fallen 27 percent so far this year.
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