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news.Amgen has presented results from a study indicating that its drug Aranesp administered once-monthly maintained stable hemoglobin control in chronic kidney disease patients with anemia not receiving dialysis, who were previously receiving Aranesp dosed every other week.
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Amgen now expects to file new data with the FDA on extended dosing regimens for Aranesp in chronic kidney disease (CKD) by the end of 2005.
In the study 85% of the patients who completed the study successfully maintained hemoglobin levels of greater than or equal to 11g/dL. Most adverse events were mild to moderate in severity and no patients reported treatment-related serious and life-threatening adverse events.
“Administering Aranesp once-monthly provides patients, physicians and nurses with significant advantages, as it allows CKD-related anemia to be treated more conveniently with fewer office visits,” said Dr Marcia Silver, director, hemodialysis program division of nephrology and hypertension, MetroHealth Medical Center.
The data were presented at the American Society of Nephrology annual meeting.