title: Etelcalcetide: First Global Approval.
abstract: Etelcalcetide (Parsabiv™) is a novel second generation calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT), a complication of chronic kidney disease (CKD). Etelcalcetide reduces circulating levels of parathyroid hormone and calcium by binding directly to the calcium-sensing receptor. Intravenous etelcalcetide has been approved in the EU for the treatment of SHPT in adult patients with CKD on haemodialysis therapy. Regulatory applications for etelcalcetide in SHPT are also under review in the USA and Japan. This article summarizes the milestones in the development of etelcalcetide leading to this first global approval for the treatment of SHPT.
authors.affiliation: Springer, Private Bag 65901, Mairangi Bay 0754, Auckland, New Zealand. dru@adis.com.
authors.forename: Hannah A
authors.initials: HA
authors.lastname: Blair
mesh_terms: D002118:Calcium / Q000378:metabolism; D017277:Drug Approval / Q000379:methods; D055808:Drug Discovery / Q000379:methods; D006801:Humans; D006962:Hyperparathyroidism, Secondary / Q000188:drug therapy* / Q000378:metabolism; D010281:Parathyroid Hormone / Q000378:metabolism; D010455:Peptides / Q000627:therapeutic use*
chemical_list: D010281:Parathyroid Hormone; D010455:Peptides; C583569:etelcalcetide hydrochloride; D002118:Calcium