Bone Care Hectorol sNDA "approvable"
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Bone Care International is preparing a written response to FDA's Oct. 25 "approvable" letter for Hectorol (doxercalciferol) capsules. Approval depends on "satisfactory response" to questions about the firm's clinical trial and agreement on labeling. The sNDA covers secondary hyperparathyroidism in chronic kidney disease patients prior to dialysis. Hectorol is currently approved for chronic renal dialysis patients. Bone Care says it does not intend to seek the indication for its injectable Hectorol formulatio
You may also be interested in...
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...
Can Organovo Leverage Its Solid Phase II Data In MASH?
Cash-limited Organovo has an FXR agonist showing competitive efficacy and tolerability in MASH, but may need a partner to move forward in that disease as it may be prioritizing its IBD program.
Cullinan Changes Tracks, Moving Lymphoma Bispecific Into Autoimmune
The company will discontinue its trial of the CD19-directed bispecific CLN-978 in NHL and develop it in inflammatory diseases, where it could have an edge over CAR-Ts.