Calcifediol extended-release capsules have received FDA approval for the treatment of secondary hyperparathyroidism (SHPT) associated with vitamin D insufficiency in patients with chronic kidney disease (CKD) stages 3 and 4.

The approval is based on a 2 randomized, double-blind, placebo-controlled phase 3 studies and an open-label extension study. Results from the 26-week placebo-controlled studies showed that a larger proportion of patients with CKD stages 3 or 4 and SHPT and vitamin D insufficiency (serum total 25-hydroxyvitamin D levels less than 30 ng/mL) achieved reductions of 30% or greater in plasma intact parathyroid hormone when treated with the patented calcifediol formulation than with placebo. In addition, vitamin D insufficiency was corrected in more than 80% of patients who received calcifediol versus less than 7% of placebo recipients.

The drug, which is being marketed under the trade name RAYALDEE by its manufacturer, OPKO Health Inc., based in Miami, is not indicated for the treatment of SHPT in patients with CKD stage 5 or end-stage renal disease on dialysis.

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Potential side effects of the calcifediol product include hypercalcemia and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed to abnormally low levels, the company said in a press release.

OPKO said it expects to launch the product later this year.

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