FDA Rejects Application for Calcimimetic Agent Etelcalcetide (Parsabiv)

Amgen has not released the details

The FDA has issued a complete response letter with regard to a new drug application (NDA) for etelcalcetide (Parsabiv, Amgen) for the treatment of secondary hyperparathyroidism (sHPT) in adults with chronic kidney disease (CKD) on hemodialysis.

Amgen didn’t supply specifics. The company said it is reviewing the letter and anticipates a post-action meeting with the FDA later this year.

Amgen acquired etelcalcetide as part of its acquisition of KAI Pharmaceuticals in July 2012. The company’s NDA was based on results from three phase 3 studies. In one of these studies, 74% of the patients receiving etelcalcetide showed a more than 30% decrease in PTH levels.

Etelcalcetide is a calcimimetic agent under investigation for the treatment of sHPT in adults with CKD on hemodialysis and is administered intravenously at the end of the hemodialysis session. A calcimimetic is a drug that mimics the action of calcium by activating the calcium-sensing receptors on the parathyroid gland. Etelcalcetide binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby reducing parathyroid hormone (PTH) levels.

A chronic and serious condition, sHPT affects many of the approximately two million people throughout the world who are receiving dialysis, including 468,000 people in the United States. Approximately 88% of dialysis patients and 79% of patients on hemodialysis will develop sHPT, which refers to the excessive secretion of PTH by the parathyroid glands in response to decreased renal function and impaired mineral metabolism. The elevated levels of PTH can lead to an increase in the release of calcium and phosphorus from the bones. Initially, sHPT is often silent and asymptomatic; as a result, it is often underdiagnosed and undertreated.

Sources: Amgen; August 24, 2016; and BioSpace; August 25, 2016.