Amgen recently released a statement regarding its receipt of a U.S. Food and Drug Administration (FDA) Complete Response Letter to the company’s New Drug Application for Parsabiv (etelcalcetide), a candidate for treating secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) who are receiving hemodialysis.
While no details were given in the statement, a Complete Response Letter received by a drug company from the FDA indicates that the drug will not be approved in its current form. The company says it is reviewing the letter in anticipation of a “post-action meeting” with the FDA later this year. The company’s regulatory submissions for Parsabiv in other regions is not affected.
The FDA accepted Amgen’s application for Parsabiv in 2015 based on data from three Phase 3 studies, two of them placebo-controlled trials involving more than 1,000 patients, and a head-to-head study evaluating Parsabiv compared with Amgen’s orally administered calcimimetic drug Sensipar (cinacalcet).
According to National Kidney Foundation data supported by journal articles cited in the AmGen statement, sHPT is a serious chronic condition affecting a significant proportion of the approximately 2 million people worldwide who are on dialysis. Often initially silent, asymptomatic, and frequently underdiagnosed and undertreated, sHPT involves excessive parathyroid hormone (PTH) secretion by the parathyroid glands in response to decreased renal function and impaired mineral metabolism.
Amgen’s Parsabiv (etelcalcetide) is a new calcimimetic agent currently undergoing investigation for treating sHPT in adult CKD patients on hemodialysis. It is administered intravenously at the end of the hemodialysis session.
Calcimimetics are drugs that mimic calcium’s action by activating calcium-sensing receptors on the parathyroid gland, thereby decreasing PTH levels. If approved, etelcalcetide would be the first calcimimetic agent that can be administered intravenously.
In a November 2015 press release, Amgen’s Vice President of Research and Development Dr. Sean E. Harper said the company was looking forward to advancing the drug toward FDA approval.
“Etelcalcetide has a novel method of administration that has the potential to help fill an unmet need for the many patients impacted by secondary hyperparathyroidism,” he said.