16 July 2018 - OPKO Health announced today that the Company’s partner Vifor Fresenius Medical Care Renal Pharma has received approval from Health Canada to market Rayaldee in Canada for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

Rayaldee is an extended-release prohormone of calcitriol, the active form of vitamin D3. The product is the first and only such therapy approved by the U.S. FDA that both raises serum 25-hydroxyvitamin D and lowers blood levels of intact parathyroid hormone. Rayaldee is indicated in the U.S. for the treatment of SHPT in adults with stage 3 or 4 chronic kidney disease and vitamin D insufficiency. It is not indicated in patients with stage 5 CKD or end stage renal disease on dialysis.

OPKO Health launched Rayaldee in the U.S. in November 2016.

Read OPKO Health article