FDA to review use of phosphate binders in CKD patients

WASHINGTON—The U.S. Food and Drug Administration’s Cardiovascular and Renal Products Advisory Committee will meet October 16 to discuss the use of phosphate binders in chronic kidney disease patients not on dialysis.

“The committee will discuss regulatory considerations for extending the use of phosphate binders from the dialysis population (where they are approved) to the predialysis population (where no products are approved),” the FDA write in the August 14 Federal Register.

The panel has invited the three companies that market phosphate binders--Shire Development, Genzyme Corp. and Fresenius Medical Care--to present at the meeting. Shire produces Fosrenol, Genzyme produces Renagel, and Fresenius produces PhosLo.

These phosphate binders are used to treat hyperphosphatemia, which is when the body contains too much phosphorus. The condition is common in kidney disease patients as the kidneys can no longer filter out the excess phosphorus.

According to Genzyme, the companies have outlined their position for the committee to consider. The briefing package included the following points.

• Phosphate imbalance precedes the need for dialysis in patients with CKD, and should be treated at the time that patients begin to experience hyperphosphatemia.
• 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 predialysis population.
• And the risk-benefit profile of appropriate early treatment f hyperphosphatemia in CKD patients not on dialysis is favorable.

Genzyme said the committee is expected to vote on whether it recommends that the FDA extend the use of phosphate binders to predialysis CKD patients.

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