Amgen’s Aranesp gets widened dosing schedule

The new approval means Aranesp (darbepoetin alfa) can be used every three weeks for patients with non-myeloid malignancies experiencing anemia (low red blood cell count), rather than being taken every week as before. The FDA acceptance makes Aranesp the only erythropoiesis-stimulating agent approved for three-week administration.

Anemia can negatively affect patients and impact their daily activities, often resulting in comorbid symptoms such as fatigue, trouble breathing or rapid heartbeat. This means regular medical attention is needed to control the problem; attention which can be time consuming for both patients and caregivers.

Reducing the number of visits required for anemia treatment with less frequent dosing and by trying to synchronize anemia treatment with other naturally occurring visits, could reduce the amount of time required for anemia treatment.

“In clinical studies, Aranesp has proven effective in reducing the incidence of red blood cell transfusions and boosting and maintaining target hemoglobin levels when administered every three weeks,” said Dr Ralph Boccia, director of clinical research, Center for Cancer and Blood Disorders, Bethesda. “Now, this less frequent dosing means patients can visit the doctor less frequently, which can result in less time away from loved ones and daily activities.”

The update to the Aranesp label now includes a recommended starting dose of 500mcg once every three weeks in addition to the recommended starting dose of 2.25mcg/kg once weekly. The new dosing recommendations are based on a randomized, double-blind, phase III study that evaluated the safety and effectiveness of every-three-week administration of Aranesp.

Sales of Aranesp products totaled $3,273 million in fiscal 2005, already representing an increase of 32.3% over the previous year before this widened dosing regime.