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Rayaldee Approval History

Rayaldee (calcifediol) is a vitamin D3 analog indicated for the treatment of secondary hyperparathyroidism associated with vitamin D Insufficiency in stage 3-4 chronic kidney disease.

The safety and efficacy of Rayaldee was established from the results of two 26 week placebo controlled, double blind phase 3 trials of 213 patients with secondary hyperparathyroidism, stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels between 10 and 30 ng/mL. Data demonstrated that a larger proportion of patients achieved at least 30 percent reductions in plasma intact parathyroid hormone (iPTH) when treated with Rayaldee than with placebo. Vitamin D insufficiency was corrected in more than 80% of the patients receiving Rayaldee compared with less than 7% of subjects receiving placebo.

Rayaldee is an extended release capsule taken orally, once daily at bedtime. The most common side effects reported in clinical trials were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation.

Development History and FDA Approval Process for Rayaldee

DateArticle
Jun 21, 2016Approval FDA Approves Rayaldee (calcifediol) to Treat Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease
Apr 27, 2016FDA Accepts Resubmission of New Drug Application for Rayaldee
Mar 30, 2016OPKO Receives Complete Response Letter from FDA for Rayaldee New Drug Application
Jul 28, 2015FDA Accepts OPKO's New Drug Application for Rayaldee
Jun  2, 2015OPKO Announces Submission of Rayaldee NDA

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