FDA approves Amgen’s Parsabiv drug to treat chronic kidney disease
The U.S. Food and Drug Administration approved Amgen’s Parsabiv drug to treat patients with chronic kidney disease, the company announced on Feb. 7.
The Thousand Oaks-based biotech company’s Parsabiv is the first therapy approved for the treatment of secondary hyperparathyroidism for patients on hemodialysis in 12 years, Amgen said.
“We are excited about today’s approval of Parsabiv in the U.S. and the opportunity to provide patients and health care providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis,” Dr. Sean Harper, executive vice president of research and development, said in a news release.
Secondary hyperparathyroidism refers to the excessive secretion of parathyroid hormone in response to decreased renal function and impaired mineral metabolism. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, decreasing the output of the overactive parathyroid hormone. It is a novel calcimimetic that can be delivered intravenously at the end of dialysis and can reduce parathyroid levels for up to 78 weeks, Amgen said.
“The ability to provide my patients with an intravenous calcimimetic and help ensure they receive the therapy they need is a tremendous milestone in the management of this frequently undertreated chronic progressive disease,” nephrologist Dr. Geoffrey Block said in a news release.
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