FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Parsabiv (etelcalcetide)

Indication:

Secondary hyperparathyroidism in adults with chronic kidney disease (CKD) on hemodialysis

Mechanism:

Binds to the calcium-sensing receptor (CaSR) and enhances activation of the receptor by extracellular calcium. Activation of the CaSR on parathyroid chief cells decreases PTH secretion.

Dosage:

5 mg IV bolus injection 3 times per week at the end of hemodialysis treatment. Individualize and determine maintenance dose by titration based on parathyroid hormone (PTH) and corrected serum calcium response. Dosage range: 2.5-15 mg IV 3 times per week.

Approval:

Approval was based on a study that compared etelcalcetide with cinacalcet. The estimated difference in proportions of patients achieving reduction in PTH concentrations of >30% between the 198 of 343 patients (57.7%) randomized to receive cinacalcet and the 232 of 340 patients (68.2%) randomized to receive etelcalcetide was -10.5% (P for noninferiority, <0.001; P for superiority, 0.004). Additionally, 178 patients (52.4%) randomized to etelcalcetide achieved >50% reduction in PTH concentrations, compared with 138 patients (40.2%) randomized to cinacalcet (P=0.001).

Reference:

Block GA, et al. Effect of etelcalcetide vs cinacalcet on serum parathyroid hormone in patients receiving hemodialysis with secondary hyperparathyroidism: a randomized clinical trial. JAMA. 2017 Jan 10;317(2):156-64.

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