FDA Accepts Amgen’s NDA for Etelcalcetide
The FDA has accepted Amgen’s NDA for etelcalcetide for treatment of secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. The agency has set a PDUFA target action date of Aug. 24, 2016.
Etelcalcetide, which is administered intravenously three times per week at the end of each dialysis session, is a calcimimetic agent that suppresses the secretion of parathyroid hormone (PTH). It works by binding to and activating the calcium-sensing receptor on the parathyroid gland.
The NDA was based on data from three Phase 3 studies, including two placebo-controlled trials in more than 1,000 patients, and a head-to-head study evaluating etelcalcetide versus cinacalcet.
That study met the primary endpoint of noninferiority versus cinacalcet, measured as the proportion of patients achieving a greater than 30 percent reduction from baseline in mean predialysis serum intact PTH. In addition, etelcalcetide was superior to cinacalcet in the secondary endpoints of the proportion of patients achieving greater than 30 percent and greater than 50 percent reduction in PTH from baseline during the EAP.