Ursodiol Cleared In USA For Liver Disease

Axcan of Montreal, Canada, and partner Schwarz of the USA have beengranted US approval to market Urso (ursodiol) 250mg tablets as an orphan drug for the treatment of primary biliary cirrhosis, a chronic, cholestatic liver disease of unknown origin. The drug will be marketed in the USA by Axcan Schwarz LLC, a joint venture between the two firms.

Axcan is only the fourth Canadian public health care company to get a New Drug Application approval from the FDA after BioChem Pharma, QLT PhotoTherapeutics and Biovail. The company says the product should be on the market in the USA in the first quarter of 1998.

A double-blind study of 180 PBC patients looked at treatment failure as the main efficacy endpoint (defined as either death, liver transplantation, doubling of serum bilirubin, histological progression, cirrhosis, varices, ascites, encephalopathy, pruritus, inability to tolerate the drug or voluntary withdrawal). After two years of treatment, the incidence of treatment failure was significantly reduced in the ursodiol group compared to placebo; 23% vs 47%.