FDA Approves New Option for Hyperparathyroidism
The FDA has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adults with chronic kidney disease who are on hemodialysis. The drug is the first therapy approved to treat HPT in 12 years.
The approval was based largely upon data from two 26-week, randomized, double-blind, placebo-controlled phase 3 studies involving 1023 patients with moderate-to-severe secondary HPT on hemodialysis. The participants were randomly assigned to received either intravenous Parsabiv or placebo 3 times a week, in addition to standard care. The primary endpoint was the proportion of patients achieving greater than 30% reduction from baseline in parathyroid hormone (PTH) during weeks 20 through 27 of the studies.
In both studies, individuals taking Parsabiv were significantly more likely to have a greater than 30% reduction from baseline in PTH (77% vs 11% and 79% vs 11% in each study, respectively) and to have PTH levels of 300 pg/mL or less during weeks 20 through 27 (52% vs 6% and 56% vs 5%, respectively).
Parsabiv is contraindicated in patients with hypersensitivity to etelcalcetide or any of its excipients. Adverse reactions most commonly reported include blood calcium decreases, muscle spasms, diarrhea, nausea, vomiting, headache, hypocalcemia, and paresthesia.
Amgen. FDA approves Amgen's Parsabiv™ (Etelcalcetide), first new treatment in more than a decade for secondary hyperparathyroidism in adult patients on hemodialysis [press release]. Thousand Oaks, California. February 7, 2017. http://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/.