The US Food and Drug Administration (FDA) has approved Amgen’s Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on haemodialysis.
Parsabiv can be administered intravenously three times a week at the end of the haemodialysis session.
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Amgen research and development executive vice-president Sean Harper said: "We are excited about today's approval of Parsabiv in the US 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 haemodialysis.
"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 healthcare professional."
Secondary HPT occurs in patients in stage five of CKD and refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to decreased renal function and impaired mineral metabolism.
Parsabiv activates the calcium-sensing receptor on the parathyroid gland, thereby causing a decrease in PTH.
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By GlobalDataIt has been demonstrated to reduce levels of PTH, corrected calcium and phosphate.
The approval of Parsabiv in the US was based on data from two randomised, double-blind placebo-controlled Phase III studies, both of which met their primary endpoints.
As part of the study, an aggregate of 1,023 patients with moderate-to-severe secondary HPT on haemodialysis were randomised to receive intravenous Parsabiv or placebo three times a week.
