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OPKO Health Says FDA Approves NDA For RAYALDEE

OPKO Health Inc. (OPK) announced that the U.S. Food and Drug Administration has approved RAYALDEE (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism or 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).

Results from two 26 week placebo controlled, double blind phase 3 trials demonstrated that a larger proportion of stage 3 or 4 CKD patients with SHPT and vitamin D insufficiency achieved =30% reductions in plasma intact parathyroid hormone (iPTH) when treated with RAYALDEE than with placebo.

Vitamin D insufficiency was corrected in more than 80% of the patients receiving RAYALDEE compared with less than 7% of subjects receiving placebo. Mean serum calcium and phosphorus levels increased by 0.1 mg/dL during RAYALDEE treatment compared to placebo treatment, but these changes were deemed clinically irrelevant. No differences in RAYALDEE's efficacy or safety were observed between patients with stage 3 CKD or stage 4 CKD.

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