Posted by Michael Wonder on 08 Apr 2024
EMA says it will consider conditional approval for NASH drugs using intermediate outcomes
5 April 2024 - The EMA said in a new reflection paper that it will consider granting conditional marketing approval to sponsors developing treatments for non-alcoholic steatohepatitis (NASH) based on the use of intermediate outomes to address a high unmet need for these products.
The paper addresses non-cirrhotic NASH, fibrosis stage 2 and 3, and cirrhotic NASH (fibrosis stage 4).
