Biotechnology pioneer, Amgen, recently announced it has submitted a New Drug Application (NDA) to the US Food and Drug Administration for its investigational drug etelcalcetide (formerly known as AMG 416), indicated as a potential treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) who are currently undergoing hemodialysis. If the NDA for etelcalcetide is approved, it will be the first calcimimetic agent that can be infused intravenously at the end of a dialysis session.

“Secondary hyperparathyroidism is a serious, progressive disease that can lead to significant clinical consequences and is also associated with a high pill burden for patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to working with regulatory authorities during the review process to bring this important treatment to market, helping to fill an unmet need for the many patients impacted by this disease.”

Etelcalcetide is a breakthrough calcimimetic agent that results in the suppression of the secretion of parathyroid hormone, an essential regulation in patients with compromised renal function as elevated parathyroid hormone levels can induce hypercalcemia and result in renal stones. The drug is given intravenously thrice weekly at the end of each dialysis session.

Amgen submitted the NDA with supporting, positive findings from three Phase III clinical studies, all of which were successful in meeting set primary endpoints, including a pair of pooled placebo-controlled trials that tested the drug on 1,000 patients, and a head-to-head study evaluating the drug’s performance compared to cinacalcet.

CKD is a medical condition characterized by the gradual loss of kidney function over time that can eventually lead to kidney failure, a situation in which the patient will have to undergo either dialysis or a kidney transplant. CKD can be caused by disorders like diabetes or high blood pressure, and is associated with an increased risk of cardiovascular diseases. It is estimated that 26 million American adults suffer from the disease.

Awareness of chronic kidney disease, defined by kidney damage or reduced glomerular filtration rate, remains low in the United States and few estimates of its future burden exist. To address this unmet issue a recent study published in the American Journal of Kidney Diseases showed that for an individual, lifetime risk of CKD is high, with more than half the US adults aged 30 to 64 years likely to develop CKD.