FDA Accepts Amgen’s NDA for Etelcalcetide

Amgen reports that the US Food and Drug Administration (FDA) has accepted for review Amgen’s new drug application (NDA) for etelcalcetide for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

Etelcalcetide is a 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 parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.

The NDA, submitted on August.24, 2015, is based on data from three Phase III studies. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of August 24, 2016, for the etelcalcetide application.

In Septmeber 2015, Amgen submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for etelcalcetide.

Source: Amgen

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