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FDA Backs Limits on Anemia Drugs
Amgen Inc. and Johnson & Johnson were set back in efforts to overturn Medicare limits on use of the firms' anemia drugs when U.S. drug regulators found the limitations suitable.
Payment rules set by Medicare, the U.S. healthcare program for the elderly and disabled, are "generally consistent" with prescribing information for use of the drugs in cancer patients, the Food and Drug Administration said in a letter released by Reps. Pete Stark (D-Fremont) and Henry A. Waxman (D-Beverly Hills).
Thousand Oaks-based Amgen has lost $18 billion in market value this year after its anemia medicines Aranesp and Epogen linked to heart risks. U.S. sales of Aranesp fell 19% in the second quarter after the FDA warned doctors to use the lowest doses probable. Medicare followed in July, saying it would pay for the drugs only at lower doses. Sales of J&J's Procrit fell 15% in the third quarter.
Amgen shares fell 89 cents, or 1.5%, to $56.78.