FDA Approves Rayaldee For Chronic Kidney Disease
The U.S. Food and Drug Administration (FDA) has newly approved OPKO Health’s Rayaldee (calcifediol) capsules for the treatment of minor hyperparathyroidism (SHPT) in grown up with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.Rayaldee capsules are a customized-release formulation of 25-hydroxyvitamin D3 (calcifediol) produce a new monotherapy.Kevin J. Martin, director of research in the Division of Nephrology at Saint Louis University School of Medicine, said Rayaldee is an important new option for treating these particular patients.
The great majority of SHPT cases in this patient population are associated with vitamin D insufficiency, a problem that Rayaldee can correct,” he said.The drug gradually restores serum total 25-hydroxyvitamin D concentrations to (or beyond) the established minimum satisfactory level of 30 ng/mL. It has a potential application as an adjunctive therapy to vitamin D hormone replacement therapy for SHPT in patients with Chronic Kidney Disease CKD.“Rayaldee fills a large void in the current treatment options for SHPT in pre-dialysis patients,” said Dr. Charles W. Bishop, CEO of OPKO’s Renal Division. The recent standard of care is big dose vitamin D is increase so reach for the treating SHPT that is neither FDA-approved nor demonstrated to be safe and successful in this population.”SHPT is a continuousely disease that becomes more and more debilitating and tough to treat and require right and effective treatment, Bishop said.
“FDA’s approval of Rayaldee represents an important milestone for OPKO,” said OPKO CEO and Chairman Dr. Phillip Frost in a press release. “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.”Two double-blind, randomized and dose-ranging placebo-controlled clinical trials are complete and have met all primary efficacy and safety endpoints. At 26 weeks, treatment with Rayaldee achieved at least a 30 percent reduction in plasma intact parathyroid hormone (iPTH) in patients with stage 3 or 4 Chronic Kidney Disease CKD with SHPT and vitamin D insufficiency, compared to those treat with a placebo.
More than 80 percent of patients treated Chronic Kidney Disease with Rayaldee saw their vitamin Dinsufficiency corrected compared with fewer than 7 percent of patients treated with the placebo.During Rayaldee treatment there was an increase by 0.1 mg/dL in the mean serum calcium levels and in phosphorus levels compared to the placebo treatment. But these changes were considered clinically irrelevant. There were no differences between patients with stage 3 CKD or stage 4 Chronic Kidney Disease CKD in Rayaldee’s efficacy or safety.