Amgen is seeking FDA approval for etelcalcetide (AMG 461), the first calcimimetic agent administered intravenously after dialysis to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD).

SHPT is a common and serious condition that is often progressive among CKD patients. It usually manifests as high amounts of parathyroid hormone (PTH) associated with abnormal calcium and phosphorus levels in the body.

Etelcalcetide binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH levels. It is administered intravenously 3 times per week at the end of each 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," stated Sean Harper, 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."

The submission for etelcalcetide includes data from a trio of phase 3 studies, including 2 pooled placebo-controlled trials in more than 1000 patients and a head-to-head study that compared the drug with cinacalcet (Sensipar), the first oral calcimimetic agent approved by the FDA for the treatment of SHPT in adult CKD patients on dialysis.