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Amgen gets FDA OK for extended dosing of Aranesp to treat chemotherapy-induced anemia
By Angela McDaniels
Seattle, March 27 - Amgen Inc. said the Food and Drug Administration has approved every-three-week dosing of Aranesp (darbepoetin alfa) for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
"The approval of an extended dosing protocol for Aranesp is an important milestone allowing anemia treatment to be synchronized with both weekly and every-three-week chemotherapy, which are the most commonly used treatment regimens," chief medical officer Willard Dere said in a company news release.
The update to the Aranesp label now includes a recommended starting dose of 500 mcg once every three weeks in addition to the recommended starting dose of 2.25 mcg/kg once weekly.
Chemotherapy can reduce the bone marrow's ability to produce red blood cells that transport oxygen from the lungs to all of the body's muscles and organs, the company said. Anemia occurs when there are too few red blood cells and the body's tissues do not receive enough oxygen, which can make a patient feel short of breath, weak, faint and tired.
In 2006, it is estimated that 67% of the 1.3 million cancer patients who undergo chemotherapy in the United States will become anemic, according to the release.
Aranesp stimulates the protein that produces oxygen-carrying red blood cells and is the only drug of its kind approved by the FDA for every-three-week dosing.
It was approved by the FDA in 2001 for the treatment of anemia associated with chronic renal failure and in 2002 for the treatment of chemotherapy-induced anemia in patients with non-myeloid malignancies.
Amgen is a biotechnology company based in Thousand Oaks, Calif.
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