OPKO Health says FDA approves new drug application for Rayaldee
Wednesday, June 22, 2016
Fda Approves New Drug Application For Rayaldee To Treat Secondary Hyperparathyroidism Associated With Vitamin D Insufficiency In Stage 3.
Says u.s. Launch planned for 2h 2016.
Says approval based upon two randomized, double blind, placebo controlled trials and an open label extension study.
Vitamin d insufficiency was corrected in more than 80% of patients receiving rayaldee versus less than 7% of subjects receiving placebo.
4 chronic kidney disease.
Source : reuters.com
