FDA approves OPKO Health's Rayaldee for new indication

The US Food and Drug Administration has approved OPKO Health’s (NYSE: OPK)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 levels less than 30ng/mL.

Earlier this year the FDA issued a complete response letter to OPKO Health’s New Drug Application for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency, indicating observations of deficiencies at OPKO’s third-party contract manufacturer. The observations were not specific to Rayaldee manufacturing. The FDA approval comes well ahead of the anticipated Prescription Drug User Fee Act (PDUFA) date is October 22, 2016.

“FDA’s approval of Rayaldee represents an important milestone for OPKO,” noted Dr Phillip Frost, chief executive and chairman of OPKO, adding: " Rayaldee is the first product to receive FDA approval for this important indication and is one of OPKO’s many pharmaceutical products being developed for significant medical problems which will benefit from new treatment options.”