Date: 2016-04-28
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at the National Kidney Foundation Spring Clinical Meetings, in Boston, MA.
Company: Opko Health (USA - Fl)
Product: Rayaldee™ ( calcifediol - vitamin D prohormone)
Action
mechanism: Rayaldee™ is a first-in-class oral vitamin D prohormone treatment being developed for secondary hyperparathyroidism in stage 3 and 4 CKD patients with vitamin D insufficiency. It has a proprietary modified-release formulation designed to gradually and reliably raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) while avoiding upregulation of CYP24, a cytochrome P-450 enzyme that reduces the PTH lowering potency of current vitamin D supplements. Activation of calcifediol, the active ingredient in Rayaldee™, by the kidney is tightly regulated, preventing excessive elevation of serum calcium and related side effects which encumber current vitamin D hormone therapies and promote vascular and renal calcification. Once approved, Rayaldee™ is expected to address an approximate 4 million CKD stage 3 and 4 patients in the U.S. and many more, elsewhere, with SHPT and vitamin D insufficiency.
Disease: secondary hyperparathyroidism (SHPT)
Therapeutic area: Hormonal diseases - Endocrine diseases
Country:
Trial details:
Latest
news: * On April 28, 2016, OPKO Health announced that additional data on Rayaldee™ as a treatment for secondary hyperparathyroidism (SHPT) will be highlighted in a poster presentation at the National Kidney Foundation Spring Clinical Meetings, underway in Boston, MA. The data showed that plasma levels of intact parathyroid hormone (iPTH) continued to fall as serum levels of 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines. These data suggest that patients with stage 3 or 4 CKD require higher levels of serum 25D than previously thought in order to control elevated iPTH.
OPKO's poster presentation is entitled "Modified-release Calcifediol Treatment of SHPT Indicates That Higher Than Expected Serum 25D Levels May Be Required in Subjects With CKD". The poster has beeen presented by senior author Stuart M. Sprague , DO, Chief, Division of Nephrology and Hypertension , NorthShore University Health System - University of Chicago , Pritzker School of Medicine .
