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FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
Posted 8 Feb 2017 by Drugs.com
THOUSAND OAKS, Calif., Feb. 7, 2017 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session. "We are excited about today's approval of Parsabiv in the U.S. and the opportunity to provide patients and health care providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Parsabiv not only has demonstrated ... Read more