Amgen has been given green light in the USA for its Parsabiv, the cure for chronic kidney disease patients on hemodialysis to treat secondary hyperparathyroidism (HPT).
Amgen noted that the FDA approved 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.
“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,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “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.”
According to the company, often occurring in patients in Stage 5 of CKD,1,2 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. Furthermore, Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.