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FDA approves Amgen’s Parsabiv to treat secondary hyperparathyroidism
The U.S. Food and Drug Administration has approved Amgen Inc.’s Parsabiv (etelcalcetide) to treat secondary hyperparathyroidism in adult patients with chronic kidney disease 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.
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“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,” said Sean E. Harper, MD., executive vice president of Research and Development at Amgen.
The FDA had rejected the drug in August, and Amgen had to resubmit a new drug application. The European Commission approved the drug November.
The approval was largely based on data from two placebo-controlled Phase 3 studies, both of which met their primary endpoints.