OPKO Health, Inc. presented late-breaking clinical data on RAYALDEE extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia. These data, presented in a poster titled "Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression" (#TH-PO1152), indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression of chronic kidney disease (CKD) in pre-dialysis patients. progressive changes in estimated glomerular filtration rate (eGFR) were examined post-hoc in 166 patients with vitamin D insufficiency, SHPT and stage 3 or 4 CKD during one year of treatment with RAYALDEE in pivotal trials.

The average eGFR decline was 7.7% per year but differ significantly and proportionately with the achieved duration of intact parathyroid hormone (iPTH) control, defined as 100 pg/mL, being greatest (16.4%) in patients who never achieved control and least (1.7%) in those achieving consistent control. Treatment with RAYALDEE was not associated with clinically meaningful increases in serum calcium orosphorus. About RAYALDEE is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3.

The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone. RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries. Slowing CKD progression with RAYALDEE treatment is not currently an approved indication.