Parsabiv etelcalcetide regulatory update

EMA’s CHMP recommended approval of Parsabiv etelcalcetide from Amgen to treat secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis. The IV peptide calcimimetic acts on the parathyroid gland to reduce production of parathyroid hormone (PTH). Last month, FDA issued a complete response letter to Amgen for an NDA for the product (see BioCentury, Sept. 5). ...