Amgen Announces Etelcalcetide Met Primary Endpoint of Non-Inferiority vs Cinacalcet

Amgen

today presented the findings from a head-to-head Phase 3 study comparing intravenous etelcalcetide (AMG 416) with oral cinacalcet for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) receiving hemodialysis. The findings were presented today at the American Society of Nephrology (ASN) Kidney Week in San Diego. The study met the primary endpoint of non-inferiority of etelcalcetide compared to cinacalcet, measured as the proportion of patients achieving a greater than 30 percent reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels during the Efficacy Assessment Phase (EAP), defined as the period between weeks 20 and 27. Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on hemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH. Sustained elevations in PTH are known to be