GelTex Files For Approval Of RenaGel
GelTex Pharmaceuticals has filed a New Drug Application in the USA forRenaGel, its non-absorbed phosphate binder for the control of elevated phosphate levels in patients with kidney failure. Hyperphosphatemia can cause serious complications in these patients, such as renal bone disease and soft tissue and vascular calcifications.
This is the first NDA filed for a GelTex product, and if approved, RenaGel will be marketed by GelTex and Genzyme General through a 50:50 joint venture. The polymer-based product binds and removes dietary phosphorus in the gastrointestinal tract without being absorbed systemically. Its key advantage compared to competitor products is that it does not contain calcium or aluminium, which can lead to hypercalcemia and aluminium-related toxicity.
GelTex' Phase III and Phase II data were presented last week at the American Society of Nephrology meeting in San Antonio. Applications for approval in Europe will be submitted next year, according to GelTex.
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