FDA approves Opko's Rayaldee

FDA approved an NDA from Opko Health Inc. (NYSE:OPK; Tel Aviv:OPK) for Rayaldee calcifediol to treat secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. The company plans to launch the modified-release formulation of 25-hydroxyvitamin D in 4Q16. Opko has not yet set a price.

In March, FDA issued a complete response letter for Rayaldee due to deficiencies at a third-party contract manufacturer. FDA accepted Opko's resubmitted NDA in April. ...