FDA approves etelcalcetide injection for secondary hyperparathyroidism

The FDA recently approved etelcalcetide for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, according to a release from Amgen.

Etelcalcetide (Parsabiv) can be administered to patients by their dialysis health care team three times per week at the end of their hemodialysis session.

“We are excited about [the approval] of Parsabiv in the [United States] 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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “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 approval was largely based on results from two placebo-controlled phase 3 studies demonstrating that etelcalcetide was effective in lowering parathyroid hormone, albumin-adjusted calcium and phosphate levels.

“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 [hyperparathyroidism],” Geoffrey A. Block, MD, a nephrologist at Denver Nephrologists PC in Colorado, said in the release. “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.”

The FDA recently approved etelcalcetide for the treatment of secondary hyperparathyroidism in adults with chronic kidney disease on hemodialysis, according to a release from Amgen.

Etelcalcetide (Parsabiv) can be administered to patients by their dialysis health care team three times per week at the end of their hemodialysis session.

“We are excited about [the approval] of Parsabiv in the [United States] 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,” Sean E. Harper, MD, executive vice president of research and development at Amgen, said in the release. “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 approval was largely based on results from two placebo-controlled phase 3 studies demonstrating that etelcalcetide was effective in lowering parathyroid hormone, albumin-adjusted calcium and phosphate levels.

“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 [hyperparathyroidism],” Geoffrey A. Block, MD, a nephrologist at Denver Nephrologists PC in Colorado, said in the release. “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.”