Amgen announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Amgen is reviewing the Complete Response Letter, and we anticipate a post-action meeting with the FDA later this year to discuss the Complete Response.
The Complete Response Letter does not impact our regulatory submissions in other regions.
Hyperparathyroidism (sHPT) is a chronic and serious condition which affects many of the approximately two million people throughout the world who are receiving dialysis, including 468,000 people in the US. Approximately 88 per cent of dialysis patients and 79 per cent of patients on hemodialysis will develop sHPT. sHPT refers to the excessive secretion of parathyroid hormone (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. sHPT is often initially silent and asymptomatic. As a result, sHPT is frequently underdiagnosed and undertreated.
Parsabiv is a novel calcimimetic agent under investigation for the treatment of sHPT in adult CKD patients 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. Parsabiv binds to and activates the calcium-sensing receptor on the parathyroid gland, thereby decreasing PTH levels.
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