US FDA to consider phosphate binders for kidney disease

The US Food and Drug Administration's Cardiovascular and Renal Products Advisory Committee will meet on October 16 to consider the use of phosphate binders in patients with chronic kidney disease who are not on dialysis.

The FDA has asked the three companies that currently market phosphate binders for patients on dialysis - Genzyme, Shire and Fresenius - to provide perspective that will help the agency formulate its approach to extending their use 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.

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 agency extends the indications for these products to use in these patients. The briefing package and the complete list of the FDA's questions to the advisory committee are available at: http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm.