Ciba's Actigall Not Ready For Cirrhosis Approval, Says FDA

Ciba's Actigall (ursodiol) is not yet approvable for a supplemental indication of biliary cirrhosis because questions remain about the methodology, consistency and analysis of the two studies filed in support of the application, according to a US Food and Drug Administration advisory committee.

The drug is frequently used off-label for biliary cirrhosis, mainly because there is currently no satisfactory treatment for the condition. Methotrexate, ciclosporin, azathioprine and colchicine have been used with little positive effects, but no agent has been specifically approved for the condition in the USA. Ursodiol was approved in the USA in 1987 for the dissolution of radiolucent non-calcified gallstones in patients at high risk of complications with surgery or in those who refuse surgical intervention.

Ciba said it is actively working with the agency to resolve the perceived problems with the two studies. The FDA panel said that Actigall could still be approved for biliary cirrhosis, and issued a conditional approval recommendation based on further work between Ciba and the agency.