Keryx Biopharmaceuticals' KRX-101 granted fast-track status by US FDA

LONDON (AFX) - Keryx Biopharmaceuticals Inc said that the U.S. Food and Drug Administration (FDA) has designated its compound, KRX-101 (sulodexide) as a fast-track product for the treatment of diabetic nephropathy.

The FDA's fast-track program is designed to facilitate the development of new drugs intended for the treatment of serious or life-threatening conditions.

Morris Laster, MD, chairman and chief executive of Keryx Biopharmaceuticals, said: "We feel this is an important step in our ongoing effort to provide an effective therapeutic option to the millions of patients afflicted by this life-threatening medical condition."

Nephropathy, one of the most common complications of diabetes, results in the degradation of kidney function. In advanced cases the patient must either undergo regular dialysis or obtain a kidney transplant to survive.

The goal of treatment, therefore, is to slow the rate of kidney damage and to control related complications.

Based on a recent market study conducted on behalf of Keryx, the estimated market for drugs to treat this disorder exceeds 1 bln usd in the U.S. alone.

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