EU approves Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism - Amgen

Amgen has announced that the European Commission (EC) has granted marketing authorization for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first calcimimetic agent that can be administered intravenously by a healthcare provider three times a week at the end of a hemodialysis session.

The EC approved Parsabiv based on three Phase III studies, all of which met their primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients, and a head-to-head study with cinacalcet. Additionally, etelcalcetide was superior to cinacalcet for the secondary endpoints of proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in mean parathyroid hormone (PTH) during the Efficacy Assessment Phase (EAP) compared with baseline.

Comment: Parsabiv (AMG 416) is administered intravenously three times per week during CKD patients' hemodialysis treatments versus the blockbuster Sensipar (also an Amgen drug), which is an oral calcimimetic taken daily during dialysis.