Amgen files NDA at FDA for etelcalcetide to treat secondary hyperparathyroidism in patients with CKD

Amgen announced the submission of a New Drug Application (NDA) with the FDA for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on haemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session. 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 haemodialysis. 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 parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.The submission includes data from three Phase III studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet (Sensipar/Mimpara).

Comment: AMG 416 is administered intravenously three times per week during CKD patients' haemodialysis treatments compared with the blockbuster cinacalcet (also an Amgen drug), which is an oral calcimimetic taken daily during dialysis.