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Hyperparathyroidism Secondary to Renal Impairment News
FDA Approves Amgen's Parsabiv (etelcalcetide) for Secondary Hyperparathyroidism in Adult Patients on Hemodialysis
Posted 12 days ago by Drugs.com
THOUSAND OAKS, Calif., Feb. 7, 2017 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Parsabiv (etelcalcetide) for the treatment of secondary hyperparathyroidism (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 that can be administered intravenously by the dialysis health care team three times a week at the end of the hemodialysis session. "We are excited about today's approval of Parsabiv in the U.S. and the opportunity to provide patients and health care providers with a novel option to help treat a complex disease that affects a significant number of patients on hemodialysis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Parsabiv not only has demonstrated ... Read more
FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
Posted 22 Jun 2016 by Drugs.com
MIAMI--(BUSINESS WIRE) June 21, 2016 – OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved Rayaldee (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Rayaldee is a patented extended release product containing 30 mcg of a prohormone called calcifediol (25-hydroxyvitamin D3). "FDA's approval of Rayaldee represents an important milestone for OPKO," noted Dr. Phillip Frost, CEO and Chairman of OPKO. "Rayaldee is the first product to receive FDA approval for this important indication and is one of OPKO's many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options." Results from two 26 week placebo controlled, ... Read more