EMA on NASH
"For non-cirrhotic NASH, fibrosis stage 2 and 3, acceptable intermediate endpoints would be:
- The resolution of NASH – with the presence of any grade of steatosis, and no ballooning, only minimal (grade 1) lobular inflammation and no worsening of the stage of fibrosis.
- The improvement of fibrosis by at least 1 stage without any worsening of NASH, and no worsening of ballooning and lobular inflammation, and no more than 1 grade increase in steatosis."
It looks like EMA is getting close to FDA in term of endpoints for an approval of a drug for the condition. Previously EMA required an improvement of both fibrosis and the NASH score!!!
EMA says it will consider conditional approval for NASH drugs using intermediate endpoints | RAPS