Fresenius Medical Care Announces FDA Submission of New Drug Application for Phos

[jbeany]

Fresenius Medical Care Announces FDA Submission of New Drug Application for PhosLo
Jan 23 2007, 10:21 AM EST

Business Wire

Fresenius Medical Care today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food & Drug Administration (FDA) to allow the Company's proprietary phosphate binder, PhosLo to be labeled for use by patients diagnosed with Stage 4 chronic kidney disease (CKD).

The U.S. National Kidney Foundation divides kidney disease into five stages depending on the glomerular filtration rate (GFR) which ranges from more than 90 ml/min in healthy kidneys (Stage 1) to less than 15 ml/min (Stage 5) where dialysis or a kidney transplant is needed. Persons with CKD Stage 4 have advanced kidney damage with a severe decrease in the GFR to 15-29 ml/min, i.e. the filtration rate is significantly lower compared to average healthy kidneys. It is likely someone with Stage 4 CKD will need dialysis or a kidney transplant in the near future. There are approximately 400,000 patients with Stage 4 CKD in the U.S.

The submission of the sNDA is based on data from the "Effect of Calcium Acetate on Phosphorus Levels in Patients with Advanced Chronic Kidney Disease" (EPIC) study. The study, which was presented at the International Society of Nephrology meeting in Copenhagen, Denmark, October 13, 2006, was a prospective, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of PhosLo in Stage 4 CKD patients. The study achieved its primary endpoint of superior control of serum phosphorus levels (p=0.0003), the calcium-phosphorus product (p=0.001) and serum parathyroid hormone (PTH) (p=0.001) versus placebo.

Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are pleased with the outcome of the EPIC study, which has resulted in the FDA submission. When the application is granted, PhosLo will provide nephrologists another therapeutic option that will allow them to start treatment of hyperphosphatemia earlier."




Is this just a formality?  My doc had me on Phoslo long before I started dialysis.  He never told me it was actually an off-label scrip.  Not that I'm complaining, mind you, just wondering if this is common.