After a rejection last year by the U.S. Food and Drug Administration (FDA) and the need for a complete response letter explaining data, Amgen (Thousand Oaks, CA) now has gained FDA approval for its drug Parsabiv. Approved in early February, the drug treats secondary hyperparathyroidism (secondary HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
Parsabiv is the first therapy approved for this condition in 12 years and the only calcimimetic drug that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session, Amgen stated.
Parsabiv has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations.
The drug mimics the action of calcium by activating calcium-sensing receptors on the parathyroid gland, which in turn decreases levels of parathyroid hormone, reports Thomson Reuters news agency. Annual sales of the drug are forecast to exceed $600 million by 2023.
