Amgen has submitted a new drug application with the U.S. Food and Drug Administration for etelcalcetide (formerly AMG 416) to treat secondary hyperparathyroidism in patients with chronic kidney disease on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session.
Etelcalcetide is a calcimimetic agent that suppresses the secretion of parathyroid hormone. It is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone. Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.
The submission includes data from three Phase 3 studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with Amgen’s drug cinacalcet (Sensipar).
Sensipar is the first oral calcimimetic agent approved by the U.S. Food and Drug Administration for the treatment of SHPT in adult patients with CKD on dialysis. Patents for the drug begin expiring this year, and the last patent is set to expire in 2018.
A district court in Delaware has blocked Teva Pharmaceuticals Industries Ltd., and Barr Laboratories Inc. from commercializing generic versions of Sensipar until the patents expire.