FDA panel recommends phosphate binder use in stage 4 CKD

WASHINGTON —A federal healthcare panel voted October 16 in favor of extending the use of phosphate binders for use in predialysis kidney disease patients with elevated levels of phosphorus in their bodies.

In a vote of 8 to 4 (with one member abstaining), the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee recommended that phosphate binders be used treat hyperphosphatemia in stage 4 chronic kidney disease patients.

The vote moves the three makers of phosphate binders—Genzyme, Shire and Fresenius—one step closer to being able to broaden the use of the drug. The FDA committee’s recommendation, however, is not binding to the FDA. And no timetable has been set by the agency as to whether or not it will follow the panel’s recommendation.

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 outlined their position for the committee to consider. The briefing package sent to the panel 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 of hyperphosphatemia in CKD patients not on dialysis is favorable.

The FDA panel did not reach a consensus on what kind of additional studies might be required to convince the FDA of expanding phosphate binder use to earlier stages of CKD in the future.