FDA approves Opko’s Rayaldee

SILVER SPRING, Md. — The Food and Drug Administration has approved Opko Health’s Rayaldee (calcifediol) extended-release capsules, the company announced Tuesday. The drug is indicated to treat secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease and a serum total 25-hydroxyvitamin D level of less than 30 ng/mL. 

 

“Rayaldee fills a large void in the current treatment options for SHPT in predialysis patients,” Opko renal division president Dr. Charles W. Bishop said. “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. SHPT is a progressive disease that becomes increasingly debilitating and difficult to treat, necessitating timely and effective treatment.”

 

The company expects Rayaldee to be available in the second half of 2016.