AMG 416 (etelcalcetide) filed with EU for secondary hyperparathyroidism- Amgen
Amgen announced the submission of a Marketing Authorisation Application to the European Medicines Agency via the centralised procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.
The MAA submission for etelcalcetide includes data from 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 evaluating etelcalcetide compared with cinacalcet.
Comment: AMG 416 is administered intravenously three times per week during CKD patients' haemodialysis treatments versus the blockbuster Sensipar/Mimpara (also an Amgen drug), which is an oral calcimimetic taken daily during dialysis.
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