Amgen files for EU approval of etelcalcetide

7 September 2015

US biotech major Amgen (Nasdaq: AMGN) has submitted a Marketing Authorization Application to the European Medicines Agency via 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 approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously. Last month, Amgen submitted a New Drug Application for etelcalcetide to the US Food and Drug Administration (The Pharma Letter August 25).

Potential to fill unmet need

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