Amgen announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) through the centralized procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy. If the application is approved by the EMA, etelcalcetide will be the first calcimimetic agent available as an intravenous drug.
Etelcalcetide is a breakthrough calcimimetic agent that inhibits the secretion of the parathyroid hormone, currently undergoing clinical testing for the treatment of SHPT in patients with CKD on hemodialysis. The drug is administered intravenously thrice weekly at the end of each dialysis session. It works by binding to and activating calcium-sensing receptors on the parathyroid gland, which causes a decrease in parathyroid hormone (PTH).
“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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”
Amgen’s MAA is based on three Phase III clinical studies, all of which were successful in meeting their set primary endpoints, along with two pooled placebo-controlled trials in over 1,000 patients and a head-to-head study evaluating etelcalcetide versus cinacalcet.