EU may warn on drugs for anemia

Amgen Inc. said Thursday that European regulators had proposed special warnings and reduced dosing recommendations for the use of anemia drugs, including its top-selling Aranesp.

The new prescribing information may say that studies show more deaths associated with increased dosing of anemia medications and that the drugs haven’t been shown to improve overall survival in cancer patients with anemia, Thousand Oaks-based Amgen said.

A panel of the European Medicines Agency recommends that anemia drugs be given to boost hemoglobin levels to 10 to 12 grams per deciliter of blood, from previous guidance of 11 to 14 grams, in kidney failure patients.

Hemoglobin carries oxygen in red blood cells, which are depleted in anemia patients. This month, advisors to the U.S. Food and Drug Administration voted against lowering recommended dosing of anemia drugs to 11 grams, keeping the maximum at 12 grams.

“Our discussions with industry contacts indicate that anemia management in Europe is much more conservative than in the U.S., and as such, a regulatory backlash akin to the U.S. situation is not expected,” said analyst Geoffrey Meacham of JPMorgan.

Amgen rose 48 cents to $56.56.

U.S. prescribing information for Aranesp, which generated $6.6 billion in sales last year, advises using the lowest dose of the drug to achieve hemoglobin targets and warns that it and other anemia medications increase the risk of death and heart complications when given to reach hemoglobin levels greater than 12 grams.

“Our discussions with the FDA and European regulators are ongoing,” Amgen spokesman Dan Whelan said.