FDA approves Rayaldee (calcifediol) for secondary hyperparathyroidism in chronic kidney disease- OPKO Health

OPKO Health announced that the 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. 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 at least 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.