DELURSAN (ursodeoxycholic acid), bile acid

High clinical benefit for hepatobiliary disorders associated with cystic fibrosis in children over the age of 6 years, but no demonstrated clinical benefit in the management of this disease in this population.

• DELURSAN has been granted marketing authorisation for the treatment of hepatobiliary disorders associated with cystic fibrosis in children aged 6 to 18 years.

• The available clinical data confirm its effect, based exclusively on the drop in liver transaminases.

• Despite the lack of clinically-relevant data concerning the efficacy of ursodeoxycholic acid, particularly in the long-term, its use is associated with significant hindsight and acceptable safety.