Rx for Parathyroid Gland Condition Approved

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

/ Author:  / Reviewed by: Anyssa Garza, PharmD

(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.

Reviewed by: 
Review Date: 
June 22, 2016
Last Updated:
June 23, 2016