The U.S. Food and Drug Administration (FDA) has approved Amgen’s Parsabiv (etelcalcetide) to treat adult patients with chronic kidney disease (CKD) who are on dialysis and experience secondary hyperparathyroidism (sHPT).
“We are excited about today’s approval of Parsabiv in the U.S. 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,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a press 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 FDA approval was based on positive results from two parallel Phase 3, randomized, placebo-controlled trials (NCT01785849, NCT01788046), and a head-to-head clinical trial (NCT01896232) that compared Parsabiv administrated intravenously with Amgen’s Sensipar (cinacalcet) administrated orally.
The first two clinical trials showed that significantly more patients on Parsabiv, than those on placebo, had reduced levels of parathyroid hormone (PTH), and also calcium and phosphorus, which is usually increased in CKD patients with sHPT.
sHPT, often present in patients with CKD Stage 5, is a serious condition that involves excessive PTH secretion by the parathyroid glands in response to decreased renal function and impaired mineral metabolism. The condition affects many of the two million people worldwide on hemodialysis, including 468,000 people in the United States, according to the National Kidney Foundation.
Amgen’s Parsabiv is a new calcimimetic agent for treating sHPT in adult CKD patients on hemodialysis. It is administered intravenously three times a week at the end of the each dialysis session, and can reduce PTH, calcium and phosphorus levels.
Calcimimetics are drug agents that mimic the action of calcium on tissues by activating the calcium-sensing receptor that is expressed in various human organ tissues, including the parathyroid gland, thereby decreasing PTH levels. Parsabiv is the first approved calcimimetic drug that can be administered intravenously.
“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, MD, 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 under-treated chronic progressive disease.”
Amgen is currently conducting a multicenter, open-label clinical trial (NCT02833857) to evaluate the safety and Parsabiv’s properties in pediatric patients with sHTP at the end of hemodialysis. That trial is not yet recruiting participants.