Amgen Sensipar Label Prepares For Off-Label Use In Pre-Dialysis Population
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA-crafted labeling for Amgen’s Sensipar anticipates off-label use of the secondary hyperparathyroidism therapy in pre-dialysis patients, review documents for the NDA show.
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Sensipar Is "Major Breakthrough" For Secondary Hyperparathyroidism – FDA
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Hectorol pre-dialysis indication
Bone Care International expands use of its secondary hyperparathyroidism agent Hectorol to include pre-dialysis patients with moderate to severe chronic kidney disease with an April 23 approval; doxercalciferol is already approved for use in dialysis patients. The vitamin D hormone had been "approvable" for the pre-dialysis indication since October 2002 (1Pharmaceutical Approvals Monthly Nov. 1, 2002, In Brief). FDA is asking for a Phase IV trial "to address recommendations made in the National Kidney Foundation K/DOQI guidelines regarding safety and efficacy of doxercalciferol in lowering elevated iPTH to within accepted ranges in 'vitamin D sufficient' patients with Stages 3 and 4 [CKD]." A two-year carcinogenicity study also is requested...