"Diabetic nephropathy is the most common cause of end-stage renal disease and represents an enormous burden for the US healthcare system. Unfortunately, there are currently few treatment options available for these patients" said Don M. Bailey, President and CEO of Questcor Pharmaceuticals. "Interim results from this small, independent investigator-initiated study are encouraging and suggest that further exploration of Acthar in patients suffering from diabetic nephropathy is indeed warranted."
Diabetic nephropathy is typically defined by macroalbuminuria ”that is, a urinary albumin excretion of more than 300 mg in a 24-hour collection ”or macroalbuminuria and abnormal renal function as represented by an abnormality in serum creatinine, calculated creatinine clearance, or glomerular filtration rate (GFR). Clinically, diabetic nephropathy is characterized by a progressive increase in proteinuria and decline in GFR, hypertension, and a high risk of cardiovascular morbidity and mortality.
According to ASN estimates, more than 500,000 patients in the US suffer from ESRD and this figure is expected to grow by 50% over the next 20 years. While there are a number of different disorders of the kidney that can result in ESRD, 44% of the more than 100,000 new ESRD cases annually in the US are caused by diabetic nephropathy. Dialysis and kidney transplant are the only treatment alternatives available for patients who progress to ESRD.
A brief abstract of Dr. Tumlin's study was submitted for consideration to ASN in June 2010. This abstract, available at www.asn-online, provides a portion of the data available for analysis at that point in time. Dr. Tumlin's poster presentation on November 20 provided an expanded set of data which became available as the study further progressed.
SOURCE Questcor Pharmaceuticals, Inc.