It can be used to treat secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy.
The company said if approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.
Amgen undertook three Phase 3 studies, all of which met their primary endpoints. The company carried out two pooled placebo-controlled trials in over 1,000 patients and a head-to-head study to evaluate etelcalcetide compared with cinacalcet.
The company said etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone.
It is administered intravenously three times a week at the end of every dialysis session.
Amgen executive vice president of research and development Sean Harper said: "Secondary hyperparathyroidism affects many of the approximately two million people throughout the world on dialysis, yet there is currently no calcimimetic that can be administered intravenously at the end of scheduled dialysis sessions.
"Given that these patients take an average of 19 pills daily, there is an opportunity to improve their treatment as it relates to the administration of the therapy.
"Etelcalcetide has the potential to fill this unmet need, and we look forward to working with regulatory authorities in hopes of providing a new treatment option that could help improve the complex management of the disease."