On Monday, a FDA panel has voted in favour of the continuance of the intake of darbepoetin alpha (Aranesp) by patients suffering from chronic kidney disorders, whether or not they are put on dialysis.
The votes for endorsing the use of drug by the FDA's Cardiovascular and Renal Drugs Advisory Committee divided as 15-1. The panel approved newly formed guidelines on the usage of darbepoetin for chronic kidney patients not on dialysis.
Though, the 2009 trials of darbepoetin, an erythropoiesis-stimulating agent (ESA) found out that the drug was not effective for chronic kidney disease patients with type 2 diabetes and anemia and were not on dialysis and also increased the risk of stroke in them. As per the FDA appraisers, patients who are treated with darbepoetin alpha would require no necessity to have five blood transfusions and they just have the risk of one additional stroke per
100 patient years.
The approval has been contributed by Amgen's Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT), which showed that the patients treated with darbepoetin alfa received improvement in their fatigue, cardiac revascularization and red-cell transfusions. The results of this trail have also been listed on the drug's label.
The panelist James Gloor, MD, Chairman of pediatric nephrology at the Mayo Clinic said, "It seems like keeping this as an option available for the clinician is important".
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