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Secondary Hyperparathyroidism News
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
FDA Medwatch Alert: Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
Posted 26 Feb 2013 by Drugs.com
ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient’s death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete. BACKGROUND: Sensipar is a calcium-sensing receptor agonist indicated in adults for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid cancer and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and ... Read more