Etelcalcetide regulatory update

Ono submitted a regulatory application in Japan for etelcalcetide to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. An NDA from Amgen for etelcalcetide is under FDA review, with an Aug. 24 PDUFA date. Amgen has also submitted an MAA to EMA for the product. The IV peptide calcimimetic acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). ...