Amgen discussing Aranesp label changes


Biotechnology company Amgen stated late Thursday that it is discussing potential safety updates for its anemia drugs with the Food and Drug Administration.

The drugs are part of a class of drugs called erythropoiesis stimulating agents, or ESAs, used to treat anemia in chemotherapy and kidney-failure patients. They include Aranesp and Epogen, made by Amgen, and Johnson & Johnson's Procrit.

The FDA's Oncologic Drugs Advisory Committee will meet during the first quarter as part of its ongoing review for ESA therapies, the company said.

Earlier this year, the FDA issued requirements for stronger warnings on the drugs and asked for additional studies. The FDA issued a black box warning on the drugs, the most critical warning a drug can carry.

Amgen currently is conducting studies to further determine the possible safety risks when patients use their pharmaceuticals.

Additional safety label changes will likely be based on data from a breast cancer patient study and follow-up data from a cervical cancer patient study, Amgen said.

Shares of Amgen fell $2.05, or 3.7 percent, to $53.10 in premarket trading.

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