OPKO Submits Rayaldee NDA To FDA

(RTTNews) - OPKO Health, Inc. (OPK) said Friday that it has submitted a New Drug Application for oral Rayaldee to the U.S. Food and Drug Administration.

The NDA requests marketing approval for Rayaldee for the prevention and treatment of secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

The Rayaldee application is supported by positive data from three randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. The studies met all primary efficacy and safety endpoints.