Complete Response Letter from FDA for Parsabiv (etelcalcetide), a proposed treatment for secondary hyperparathyroidism.-Amgen
Amgen announced that the FDA has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Amgen is reviewing the Complete Response Letter, and the company anticipates a post-action meeting with the FDA later this year to discuss the Complete Response.
Comment: 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.
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