FDA Accepts GelTex Pharmaceuticals' NDA as "Filable"

GelTex Pharmaceuticals, Inc. and Genzyme General announced that the U.S. Food and Drug Administration has accepted for filing the New Drug Application (NDA) for RenaGel non-absorbed phosphate binder for the control of elevated phosphate levels in chronic kidney failure patients.

The companies also announced that RenaGel phosphate binder has received Part B status from the European Agency for the Evaluation of Medicinal Products. With Part B status, only one application need be submitted in order to obtain marketing approval in all 15 European Union countries.

Elevated serum phosphorus levels in chronic kidney failure patients can cause serious complications such as renal bone disease and soft tissue and vascular calcifications. There are an estimated 220,000 end-stage renal failure patients in the United States, 95 percent of whom receive a phosphate control product.

"The FDA's acceptance of the RenaGel NDA for review is an important first step in the regulatory review process," said Mark Skaletsky, president and CEO of GelTex. "Acceptance for filing keeps RenaGel development on schedule." Skaletsky noted that the NDA is based on six clinical trials involving approximately 400 patients.

GelTex and Genzyme General have entered into a 50-50 joint venture to complete final development and commercialization of RenaGel phosphate binder in the United States, Europe, and Canada. The U.S. NDA was submitted to the FDA in early November. Applications for marketing authorization in Europe and Canada are expected to be submitted in 1998.

RenaGel is designed to bind and remove dietary phosphorus in the gastrointestinal tract without being absorbed into the bloodstream. Unlike currently available agents, RenaGel does not contain calcium or aluminum, which can lead to hypercalcemia and aluminum-related toxicity, respectively. RenaGel is designed to allow physicians to manage phosphorus and calcium levels independently.