FDA accepts Amgen's NDA for etelcalcetide, novel intravenous calcimimetic
The US Food and Drug Administration (FDA) has accepted for review biotech major Amgen's (Nasdaq: AMGN) New Drug Application for etelcalcetide (formerly AMG 416) for the treatment of 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. The drug is also under review with the European Medicines Agency.
"We're pleased that the FDA has accepted our submission and look forward to advancing our conversations toward a potential approval in the US," said Sean Harper, executive vice president of R&D at Amgen, adding: "Etelcalcetide has a novel method of administration that has the potential to help fill an unmet need for the many patients impacted by secondary hyperparathyroidism."
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