FDA approves Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism in adult patients with chronic kidney disease on hemodialysis.- Amgen

Amgen announced that the FDA has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session.

Often occurring in patients in Stage 5 of CKD, secondary HPT refers to the excessive secretion of parathyroid hormone (PTH) by the parathyroid glands in response to decreased renal function and impaired mineral metabolism. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.

Comment: Parsabiv is administered intravenously three times per week during CKD patients' hemodialysis treatments versus the blockbuster Sensipar (also an Amgen drug), which is an oral calcimimetic taken daily during dialysis.

Comment: Also in the field for treatment of secondary hyperparathyroidism is Rayaldee (calcifediol), a vitamin D3 analogue, from Opko Health which was FDA approved in June 2016 for secondary hyperparathyroidism in adults with Stage 3 or 4 kidney disease. Rayaldee is not indicated in patients with stage 5 chronic kidney disease or end-stage renal disease on dialysis. Another candidate is DP 001 from Deltanoid Pharmaceuticals, which is in Phase II. DP001 is an oral small molecule targeting the vitamin D receptor.