Regulatory Affairs

Amgen secures FDA approval for Parsabiv drug to treat chronic kidney disease

PBR Staff Writer Published 08 February 2017

Amgen has secured approval from the US Food and Drug Administration (FDA) for Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) undergoing hemodialysis.

The company claims that Parsabiv is the first new therapy approved for the condition in 12 years.

It is designed to be administered intravenously three times per week at the end of a dialysis session.

The approval was supported by data from two placebo-controlled phase 3 studies, both of which met their primary endpoints.

The studies randomized 1,023 patients with moderate-to-severe secondary HPT (PTH greater than 400 pg/mL) on hemodialysis to receive intravenous Parsabiv or placebo three times a week, at the end of their dialysis sessions apart from standard of care that could include vitamin D and/or phosphate binders.

A greater than 30% reduction from baseline in parathyroid hormone (PTH) during the efficacy assessment phase.

In addition, greater percent reduction from baseline was achieved in Parsabiv-treated patients than placebo-treated patients during the EAP, for PTH, corrected calcium and phosphate in both studies.

Amgen executive vice president of research and development Sean Harper said: "Parsabiv not only has demonstrated strong efficacy in clinical trials; it also fills an unmet need by putting the delivery of the therapy in the hands of the health care professional."

The company did not study Parsabiv in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis. It is not recommended for use in these populations.

In November 2016, the European Commission approved Parsabiv to treat secondary hyperparathyroidism in adult patients with CKD on hemodialysis.

Image: Amgen headquarters in Thousand Oaks, California. Photo: courtesy of Coolcaesar.