DELURSAN (ursodeoxycholic acid), bile acid
MALADIE RARE - Nouvelle indication
Opinions on drugs - Posted on Oct 24 2018
Reason for request
Renewal of inclusion and Extension of indication
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.