FDA Approves Etelcalcetide for Secondary Hyperparathyroidism in Chronic Kidney Disease

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The drug's approval was based on 2 successful phase 3 trials.

Etelcalcetide (Parsabiv; Amgen) has been approved by the US Food and Drug Administration (FDA) to treat secondary hyperparathyroidism (HPT) in adults with chronic kidney disease (CKD) undergoing hemodialysis, according to a press release from Amgen.

Secondary HPT, an excessive secretion of parathyroid hormone (PTH), often occurs in stage 5 of CKD. By binding to and activating the parathyroid gland’s calcium-sensing receptors, etelcalcetide decreases PTH.

“Parsabiv has not only demonstrated strong efficacy in clinical trials, it also fills an unmet need by putting the delivery of the therapy in the hands of health care professional,” said Sean E. Harper, MD, executive vice president of research and development at Amgen, in a press release.1

Approval of etelcalcetide was based primarily on data from 2 phase 3 trials (ClinicalTrials.gov Identifiers NCT02054572; NCT01896232 Both were 26-week, randomized, double-blind, placebo-controlled studies of patients with moderate-to-severe HPT on hemodialysis.

The primary end point — the proportion of patients achieving a 30% or greater reduction from baseline PTH — was met in both trials.

Commonly reported adverse reactions were muscle spasms, diarrhea, nausea, vomiting, headache, and paresthesia/hypoesthesia.

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  1. FDA approves Amgen’s Parsabiv™ (etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis [news release]. Thousand Oaks, CA: Amgen; February 7, 2017. https://www.amgen.com/media/news-releases/2017/02/fda-approves-amgens-parsabiv-etelcalcetide-first-new-treatment-in-more-than-a-decade-for-secondary-hyperparathyroidism-in-adult-patients-on-hemodialysis/. Accessed February 13, 2017.