FDA approves first new treatment in more than a decade for secondary HPT in adults on hemodialysis

Intravenous administration puts delivery in hands of healthcare provider.

"We are excited about today's approval of Parsabiv in the US 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, executive vice president of R&D 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."

Often occurring in patients in Stage 5 of CKD, 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. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH.

"As a physician who cares for patients with advanced chronic kidney disease, I understand the importance of achieving and maintaining simultaneous reductions in a number of complex lab values in the treatment of secondary HPT," said Geoffrey A. Block, nephrologist at Denver Nephrologists, PC, in Colorado. "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."

Secondary HPT is a serious condition and the proportion of patients unable to reach recommended secondary HPT lab targets has more than doubled in the last 5 years. Sensipar (cinacalcet), the first FDA-approved calcimimetic, became an important treatment for patients with secondary HPT on dialysis based on its ability to reduce three important biochemical abnormalities (PTH, calcium, phosphorus). Parsabiv is a novel calcimimetic that can be delivered intravenously at the end the hemodialysis session and has been demonstrated to effectively reduce levels of PTH, corrected calcium and phosphate. These reductions were maintained for up to 78 weeks.