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 Rayaldee Approved for Secondary Hyperparathyroidism in Adults with CKD

06/2016

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. 

http://www.empr.com/news/rayaldee-approved-for-secondary-hyperparathyroidism-in-adults-with-ckd/article/504453/

Comment:  FDA agrees people with vitamin D levels below 30ng/ml need more D. Their solution, a prescription with an estimated price tag of $140,000 per year. Ours, www.prod5.com

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