Amgen, Inc. (AMGN) declared 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 recently’s approval of Parsabiv in the U.S. and the opportunity to provide patients and health care providers with a novel option to assist treat a complex disease that affects a noteworthynumber of patients on hemodialysis,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the health care professional.”
Often occurring in patients in Stage 5 of CKD secondary HPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to reduced renal function and impaired mineral metabolism.1,3 Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.
“As a physician who cares for patients with advanced chronic kidney disease, I understand the importance of achieving and maintaining simultaneous reductions in a number of complex lab values in the treatment of secondary HPT,” said Geoffrey A. Block, M.D., nephrologist at Denver Nephrologists, PC, in Colorado. “The ability to provide my patients with an intravenous calcimimetic and assist ensure they receive the therapy they need is a tremendous milestone in the administration of this frequently undertreated chronic progressive disease.”