FDA Approves Drug for Chronic Kidney Disease-Related SHPT, Low Vitamin D

The approximately nine million patients with advanced chronic kidney disease, low vitamin D, and secondary hyperparathyroidism (SHPT) can be treated with the first drug to be approved for the indication.

Developed by OPKO Health Inc., calcifediol (Rayaldee) extended release capsules was given the green light by the US Food and Drug Administration (FDA) on June 21. The medication contains 30 mcg of prohormone, calcifediol. It’s intended to treat SHPT in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.

• Related: People with Advanced Chronic Kidney Disease Need More Vitamin D

“The current standard of care is high dose vitamin D supplementation, an approach for treating SHPT that is neither FDA approved nor demonstrated to be safe and effective in this population,” Charles Bishop, PhD, CEO of OPKO’s Renal Division, said in a news release.

The approval was based off of two 26-week phase III trials. Results showed more patients on the medication had a plasma intact parathyroid hormone (iPTH) reduction by at least 30%. When it came to vitamin D insufficiency, Rayaldee was able to bring 80% of patients to acceptable levels while the same was found in less than 7% of those taking the placebo.

Clinically irrelevant mean serum calcium and phosphorus levels emerged with the treatment and the drug maintained its efficacy and safety profile.

Rayaldee is expected hit the US market in the second half of 2016.

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