First New Drug for Secondary HPT in Over a Decade Gets FDA Approval

The approval was based on data from two 26-week, Phase 3, randomized, placebo-controlled studies
The approval was based on data from two 26-week, Phase 3, randomized, placebo-controlled studies

Amgen announced that the Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis. 

The FDA approval was based on data from two 26-week, Phase 3, randomized, double-blind, placebo-controlled studies that enrolled 1,023 patients with moderate-to-severe secondary hyperparathyroidism (parathyroid hormone [PTH] >400pg/mL) on hemodialysis. They were randomized to receive Parsabiv or placebo 3 times weekly at the end of their dialysis sessions in addition to standard of care that could include vitamin D and/or phosphate binders.  

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For both studies, the primary endpoint was the proportion of patients achieving >30% reduction from baseline PTH during Weeks 20–27 (Efficacy Assessment Phase [EAP]). Data from the two studies showed that significantly more patients in the Parsabiv group achieved a >30% reduction from baseline PTH than the placebo group during EAP (Study 1: 77% vs. 11% and Study 2: 79% vs.11%). In addition, significantly more patients in the Parsabiv group achieved PTH levels ≤300pg/mL during EAP (Study 1: 52% vs. 6% and Study 2: 56% vs. 5%). 

Parsabiv-treated patients also showed a greater percent reduction from baseline for PTH, corrected calcium, and phosphate, compared to placebo-treated patients in both studies. 

Parsabiv, a novel calcimimetic, binds to and activates the calcium-sensing receptor on the parathyroid gland, causing decreases in PTH. This approval makes Parsabiv the first treatment for this condition in 12 years, and it is the only calcimimetic that can be given intravenously (IV) by the dialysis care team at the end of the session. 

Parsabiv will be available as a 2.5mg/0.5mL, 5mg/mL, and 10mg/2mL strength solution for IV injection in single-dose vials in 10-count cartons.

For more information call (800) 772-6436 or visit Parsabiv.com.