FDA Approves Parsabiv for Hyperparathyroidism in Adults on Hemodialysis

First new therapy for this indication in more than a decade

The FDA has approved etelcalcetide (Parsabiv, Amgen) for the treatment of secondary hyperparathyroidism (HPT) in adults with chronic kidney disease (CKD) on hemodialysis. Etelcalcetide is the first therapy approved for this condition in 12 years. In addition, it is the only calcimimetic that can be administered intravenously by the dialysis team three times a week at the end of the hemodialysis session, according to Amgen.

Secondary HPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid gland in response to decreased renal function and impaired mineral metabolism. As a calcimimetic, etelcalcetide mimics the action of calcium by binding to and activating calcium-sensing receptors on the parathyroid gland, thereby reducing PTH levels.

The FDA’s approval of etelcalcetide was based primarily on data from two phase 3 studies, both of which met their primary endpoints.

In the two 26-week, randomized, double-blind, placebo-controlled trials, a total of 1,023 patients with moderate-to-severe secondary HPT (PTH greater than 400 pg/mL) during hemodialysis were assigned to receive intravenous etelcalcetide or placebo three times a week at the end of their dialysis sessions in addition to standard of care, which could include vitamin D and/or phosphate binders. The primary endpoint of both studies was the proportion of patients achieving a reduction of greater than 30% from baseline in PTH levels during the efficacy assessment phase (EAP) of the trial (weeks 20 through 27).

The two studies showed that significantly more etelcalcetide-treated patients than placebo-treated patients achieved a reduction of greater than 30% from baseline in PTH during the EAP: 77% vs. 11%, respectively, in study 1, and 79% vs. 11% in study 2. In addition, more patients in the etelcalcetide group than in the placebo group achieved PTH levels of 300 pg/mL or less during the EAP: 52% vs. 6%, respectively, in study 1, and 56% vs. 5% in study 2.

Source: Amgen; February 8, 2017.