As expected, Medicare has changed its kidney-care guidelines to remove a requirement that helped fuel sales of Amgen's ($AMGN) anemia drug Epogen. Kidney dialysis providers were previously told to keep their patients' hemoglobin levels above 10 mg per deciliter, a minimum that could trigger drug treatment.
The agency said the requirement would be history as of 2013. The maximum hemoglobin level will remain in force. The new rules mirror labeling changes from the FDA, which has debated the safety of Epogen and a sister drug Procrit, marketed by Johnson & Johnson ($JNJ). Studies have suggested that higher dosing is linked with various health risks, including stroke, blood clots and death.
Analysts figure the rule change will result in further sales declines for Epogen, as Reuters notes. The drug has seen its revenues drop during the ongoing safety debates. Sales of Procrit and Amgen's newer version Aranesp have also dropped. Amgen itself has said that if the federal government hews to FDA's dosing limits, Epogen use could decline by up to one-quarter.
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