If etelcalcetide gets approval, it will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session.
Etelcalcetide is a new calcimimetic agent that suppresses the secretion of parathyroid hormone and is administered intravenously three times per week at the end of each dialysis session.
Amgen Research and Development executive vice-president Sean Harper said: "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.
"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 acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH).
The NDA is based on data from three Phase III studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet.
Sensipar (cinacalcet) is the first oral calcimimetic agent approved by the FDA to treat SHPT in adult patients with CKD on dialysis.
It is not indicated for use in adults with CKD who are not on dialysis because of an increased risk of hypocalcemia.
Image: If approved by the FDA, etelcalcetide will be the first calcimimetic agent that can be administered intravenously at the end of the dialysis session. Photo: courtesy of Baitong333/ freedigitalphotos.net.