The US Food and Drug Administration (FDA) approved Rayaldee (calcifediol) (OPKO Health, Miami, FL) extended-release capsules for treatment of secondary hyperparathyroidism (SHPT). The approval applies only to treating adults with SHPT who have CKD stage 3 or 4 and serum total 25-hydroxyvitamin D <30 ng/mL.
Rayaldee has a patented design intended to increase serum total 25-hydroxyvitamin D (prohormone) levels to targeted levels and also to decrease elevated intact parathyroid hormone (iPTH). It is the first drug approved for this specific purpose.
“Rayaldee is an important new option for treating SHPT in patients with stage 3 or 4 CKD and vitamin D insufficiency,” Kevin J. Martin, Director of Research, Division of Nephrology, at Saint Louis University School of Medicine, stated in the company media release. “The great majority of SHPT cases in this patient population are associated with vitamin D insufficiency, a problem that Rayaldee can correct.”
The FDA approval was based on data from two 26-week placebo-controlled, double-blind phase 3 trials that showed a greater proportion of CKD stage 3 or 4 patients with SHPT and vitamin D insufficiency achieved reductions of >30% in plasma iPTH after treatment with Rayaldee vs. placebo. More than 80% of patients receiving Rayaldee were able to correct their vitamin D insufficiency compared with <7% of patients receiving placebo.
Over-administration of calcifediol can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of intact PTH, the company noted.
Rayaldee extended-release capsules will be available in the second half of 2016.
