CAMBRIDGE, Mass., Oct. 12 /PRNewswire-FirstCall/ -- Genzyme Corporation (Nasdaq: GENZ) announced that the U.S. Food and Drug Administration's Cardiovascular and Renal Products Advisory Committee will meet Tuesday to consider the use of phosphate binders in patients with chronic kidney disease (CKD) who are not on dialysis.
FDA asked the three companies that currently market phosphate binders for patients on dialysis to provide perspective that will help the agency formulate its approach to extending the use of phosphate binders to pre- dialysis patients. In a briefing package provided to the FDA and the committee, the companies have outlined their position for the committee to consider. Specifically:
-- Phosphate imbalance precedes the need for dialysis in patients with
CKD, and should be treated at the time that patients begin to
-- Left untreated, patients experiencing hyperphosphatemia prior to the
initiation of dialysis may experience progression of renal disease,
bone disorders and vascular calcification.
-- Hyperphosphatemia is an independent risk factor for cardiovascular
morbidity and mortality, and for the progression of renal failure in
the pre-dialysis population.
-- And the risk-benefit profile of appropriate early treatment of
hyperphosphatemia in CKD patients not on dialysis is favorable.
The committee is expected to vote on several questions related to the
use of phosphate binders in pre-dialysis patients, concluding with a vote
on whether the committee recommends that the FDA extend the indications for
phosphate binders to use in these patients. The briefing package and th
|SOURCE Genzyme Corporation|
Copyright©2007 PR Newswire.
All rights reserved