BRIEF—FDA publishes guidance on developing drugs for NASH with compensated cirrhosis

The US Food and Drug Administration has issued guidance making recommendations regarding the components of a drug development program for nonalcoholic steatohepatitis (NASH) with compensated cirrhosis.

This guidance focuses on clinical outcome trials, specifically on how to evaluate whether newly-developed treatments can delay or reduce the frequency of organ failure events and other severe outcomes.

The guidance accompanies a draft guidance published in 2018 which discusses the agency’s thinking for the design of clinical trials for patients who have NASH but do not have cirrhosis.