Amgen submits MAA for etelcalcetide to the EMA

Amgen has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.

SHPT is a common and serious condition that is often progressive among patients with CKD, and it affects many of the approximately two million people throughout the world who are receiving dialysis, including approximately 350,000 people in Europe. The disorder develops early in the course of CKD and usually manifests as increased levels of parathyroid hormone (PTH) as a result of increased production from the parathyroid glands (four small glands in the neck).

Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on haemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH. Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.

Etelcalcetide MAA submission includes data from three Phase 3 studies

“Secondary hyperparathyroidism affects many of the approximately two million people throughout the world on dialysis, yet there is currently no calcimimetic that can be administered intravenously at the end of scheduled dialysis sessions. Given that these patients take an average of 19 pills daily, there is an opportunity to improve their treatment as it relates to the administration of the therapy,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Etelcalcetide has the potential to fill this unmet need, and we look forward to working with regulatory authorities in hopes of providing a new treatment option that could help improve the complex management of the disease.”

The MAA submission for etelcalcetide includes data from three Phase 3 studies, all of which met their 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.