The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) issued draft recommendations for sponsors looking to develop drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis.
NASH is associated with a range of common diseases, including type 2 diabetes, hypertension and obesity, among others. “It is a growing public health concern and is anticipated to be the leading cause of liver transplantation within a decade,” the agency says. But “no standard treatment exists for NASH.”
The guidance follows a separate draft guidance issued in December that provides recommendations for early NASH drug development and developing drugs to treat noncirrhotic NASH.
To aid sponsors of drugs to treat compensated NASH cirrhosis during clinical development, the draft guidance details the agency’s current recommendations regarding components of phase 3 programs.
Specifically, the guidance details patient enrollment criteria, clinical trial design, efficacy endpoints and safety considerations for phase 3 trials…