The U.S. Food and Drug Administration approved Amgen's Parsabiv for the treating of secondary hyperparathyroidism (HPT) in adults with chronic kidney failure and is administered at dialysis locations throughout the country.
“We are excited about today’s approval of Parsabiv, and the opportunity to provide patients and healthcare providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis,” Sean Harper, executive vice president of research and development at Amgen, said. “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.”
The number of people suffering from HPT has nearly doubled in the last five years.
"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," Geoffrey Block, a nephrologist at Denver Nephrologists, 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."
FDA approves Parsabiv for adults with kidney failure
Alerts Sign-up