Etelcalcetide regulatory update

FDA accepted for review an NDA from Amgen for etelcalcetide to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. The PDUFA date is Aug. 24, 2016. The IV peptide calcimimetic acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). Amgen has submitted an MAA to EMA for etelcalcetide (see BioCentury, Sept. 7). ...