The following information is obtained from various newswires,
published medical journal articles, and medical conference presentations.
Company: Axcan Schwarz
Approval Status: Approved December 1997
Treatment for: primary biliary cirrhosis
General Information
Urso has been approved for the treatment of primary biliary cirrhosis.
Clinical Results
The approval rested primarily on the results of two Phase III trials conducted in approximately 300 patients. A two-year 180-patient study performed by the Mayo Clinic dosed patients at 13-15 mg/kg per day with Urso tablets 250 mg four times daily. Among patients receiving Urso, 23% were considered treatment failures compared to 47% in the placebo group.
