Opko Health announced that the 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 <30ng/mL.
Rayaldee, which contains 30mcg of the prohormone calcifediol, is the first drug to be approved for this condition. Its patented design is intended to increase serum total 25-hydroxyvitamin D (prohormone) levels to targeted levels and to decrease elevated intact parathyroid hormone (iPTH).
The FDA approval was based on data from two 26-week placebo-controlled, double-blind Phase 3 trials that showed a greater proportion of Stage 3 or 4 CKD patients with SHPT and vitamin D insufficiency achieved ≥30% reductions in plasma iPTH after treatment with Rayaldee vs. placebo. Over 80% of patients receiving Rayaldee were able to correct their vitamin D insufficiency vs. <7% of patients receiving placebo.
No differences were seen in regards to the efficacy or safety of Rayaldee between patients with Stage 3 or 4 CKD. Patients treated with Rayaldee had a 0.1mg/dL increase in mean serum calcium and phosphorous levels compared to placebo but this was deemed clinically irrelevant.
Rayaldee extended-release capsules will be available in the second half of 2016.
For more information call (305) 575-4100 or visit Opko.com.