FDA posts draft guidance for developing NASH drugs

The FDA posted its draft guidance for developing drugs to treat noncirrhotic nonalcoholic steatohepatitis with liver fibrosis. Companies developing NASH treatments include Intercept Pharmaceuticals (ICPT), Genfit (GNFTF), Madrigal Pharmaceuticals (MDGL), CymaBay Therapeutics (CBAY) and Viking Therapeutics (VKTX). The patient inclusion criteria sponsors should consider for clinical trials in drug development for treatment of noncirrhotic NASH with liver fibrosis include: “Patients should have a histological diagnosis of NASH with liver fibrosis made close to the time of trial enrollment (i.e., no more than 6 months before enrollment). Because baseline histology is critical for efficacy evaluation, liver biopsies obtained more than 6 months before enrollment may not represent an accurate status of the disease at the 210 beginning of the trial,” the FDA said. It adds, “Because some NASH patients are treated with vitamin E or pioglitazone, enrollment of such patients in clinical trials may confound treatment effects. Therefore, such NASH patients should either discontinue vitamin E or pioglitazone or be on stable doses for 6-12 months before enrollment. Stratified randomization may be necessary to avoid imbalances between treatment arms for concurrent treatment with vitamin E or pioglitazone.”

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