Rx for Parathyroid Gland Condition Approved

Opko's Rayaldee (calcifediol) approved to treat high parathyroid hormone levels in those with chronic kidney disease

(RxWiki News) The US Food and Drug Administration (FDA) has approved a new medication to treat a disorder of the parathyroid glands.

That medication is Rayaldee (calcifediol). It has been approved to treat those with secondary hyperparathyroidism (SHPT) — or high parathyroid hormone levels — in those with stage 3 or 4 chronic kidney disease. Furthermore, patients must also have a vitamin D level of less than 30 ng/mL.

This medication is not indicated for those with stage 5 chronic kidney disease or end-stage renal disease on dialysis.

Opko's Rayaldee is available as an extended-release capsule and is to be taken once a day at bedtime.

Rayaldee was granted approval after it appeared effective when compared to placebo in two clinical trials. Rayaldee was found to reduce parathyroid hormone and correct low vitamin D levels.

Dr. Charles W. Bishop, CEO of OPKO's Renal Division, said he believes Rayaldee offers patients an effective treatment option.

"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," Dr. Bishop said in an Opko press release.

Common side effects may include a decrease in red blood cells (anemia), common cold, difficulty breathing, cough, congestive heart failure and constipation.

Rayaldee is expected to launch in the second half of 2016.

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Review Date: 
June 22, 2016