New Clinical Data on OPKO Health’s RAYALDEE® Presented at Ki
Nov 2, 2023 14:02:22 GMT
miamianne67, icemandios, and 1 more like this
Post by gutset on Nov 2, 2023 14:02:22 GMT
New Clinical Data on OPKO Health’s RAYALDEE® (ER Calcifediol) Presented at Kidney Week 2023
Download as PDFNovember 02, 2023
MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today. These data, presented in a poster titled “Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression” (#TH-PO1152), indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression of chronic kidney disease (CKD) in pre-dialysis patients.
Progressive changes in estimated glomerular filtration rate (eGFR) were examined post-hoc in 166 patients with vitamin D insufficiency, SHPT and stage 3 or 4 CKD during one year of treatment with RAYALDEE in pivotal trials. The average eGFR decline was 7.7% per year but differed significantly and proportionately with the achieved duration of intact parathyroid hormone (iPTH) control, defined as ≤100 pg/mL, being greatest (16.4%) in patients who never achieved control and least (1.7%) in those achieving consistent control. The number of patients experiencing an increase in eGFR by the end of treatment rose from 3.6% to 10.8% as the duration of iPTH control increased. Treatment with RAYALDEE was not associated with clinically meaningful increases in serum calcium or phosphorus.
“Secondary hyperparathyroidism is associated with more rapid CKD progression and earlier dialysis, but mitigation of disease progression by effective control of SHPT has not been previously examined,” stated Charles W. Bishop, Ph.D., CEO of OPKO Health’s Renal Division. “RAYALDEE is a safe and highly effective treatment for SHPT in patients with stage 3 or 4 CKD. The new data presented today clearly highlight the possibility that raising serum 25-hydroxyvitamin D to a sufficiently high level to achieve consistent iPTH control with RAYALDEE would improve outcomes in CKD patients.”
About RAYALDEE®
RAYALDEE is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries. Slowing CKD progression with RAYALDEE treatment is not currently an approved indication.
Download as PDFNovember 02, 2023
MIAMI, Nov. 02, 2023 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) presented late-breaking clinical data on RAYALDEE® extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia today. These data, presented in a poster titled “Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression” (#TH-PO1152), indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression of chronic kidney disease (CKD) in pre-dialysis patients.
Progressive changes in estimated glomerular filtration rate (eGFR) were examined post-hoc in 166 patients with vitamin D insufficiency, SHPT and stage 3 or 4 CKD during one year of treatment with RAYALDEE in pivotal trials. The average eGFR decline was 7.7% per year but differed significantly and proportionately with the achieved duration of intact parathyroid hormone (iPTH) control, defined as ≤100 pg/mL, being greatest (16.4%) in patients who never achieved control and least (1.7%) in those achieving consistent control. The number of patients experiencing an increase in eGFR by the end of treatment rose from 3.6% to 10.8% as the duration of iPTH control increased. Treatment with RAYALDEE was not associated with clinically meaningful increases in serum calcium or phosphorus.
“Secondary hyperparathyroidism is associated with more rapid CKD progression and earlier dialysis, but mitigation of disease progression by effective control of SHPT has not been previously examined,” stated Charles W. Bishop, Ph.D., CEO of OPKO Health’s Renal Division. “RAYALDEE is a safe and highly effective treatment for SHPT in patients with stage 3 or 4 CKD. The new data presented today clearly highlight the possibility that raising serum 25-hydroxyvitamin D to a sufficiently high level to achieve consistent iPTH control with RAYALDEE would improve outcomes in CKD patients.”
About RAYALDEE®
RAYALDEE is an extended-release (ER) oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the U.S. Food and Drug Administration for raising serum total 25D and lowering blood levels of intact parathyroid hormone (iPTH). RAYALDEE is approved to treat SHPT in adults with stage 3 or 4 CKD and vitamin D insufficiency in the U.S. and in 11 European countries. Slowing CKD progression with RAYALDEE treatment is not currently an approved indication.
