Posted by Michael Wonder on 21 Sep 2021
Inventiva announces FDA decision that fast track designation granted to lanifibranor in NASH encompasses the treatment of NASH with compensated cirrhosis
21 September 2021 - Inventiva today announced that the U.S. FDA has decided that the fast track designation previously granted to lanifibranor in non-alcoholic steatohepatitis encompasses the treatment of non-alcoholic steatohepatitis patients with compensated cirrhosis.
This decision follows a fast track designation request for lanifibranor in non-alcoholic steatohepatitis with compensated cirrhosis filed by Inventiva with the FDA in August 2021.
Previously, the FDA had granted both fast track and breakthrough therapy designations to lanifibranor for the treatment of non-alcoholic steatohepatitis in September 2019 and October 2020, respectively.
