FDA recently approved 2 new therapies: an expanded drug indication for locally advanced or metastatic urothelial carcinoma (mUC) and a treatment for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis.
As fee-for-service rapidly transforms into value-based care, the industry must improve member engagement and outcomes by using targeted care management interventions that help deliver bottom-line results across a broader spectrum of the population.
After initially rejecting calcifediol (Rayaldee, Opko Health) for chronic kidney disease earlier this year because of manufacturing concerns, FDA approved the drug four months ahead of its new timeline.
Rayaldee extended release capsules is the first drug to receive FDA approval for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.
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