Amgen Receives Complete Response Letter From FDA For ParsabivBy
Amgen has received a Complete Response Letter (CRL) from the US Food and Drug Administration (FDA) for Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. Amgen is reviewing the CRL and anticipates a post-action meeting with the FDA later this year to discuss it. The CRL does not impact the company's regulatory submissions in other regions.
Parsabiv is a 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.