Amgen hyperparathyroidism drug gains FDA approval

8 February 2017

Amgen (Nasdaq: AMGN) yesterday revealed that the US Food and Drug Administration 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, the company contends

The approval comes after a previous delay in the FDA review, when in August 2016 the agency issued a complete response letter, to which the company responded to satisfactorily.

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