The US FDA has granted accelerated approval for resmetirom to address the needs of adults diagnosed with noncirrhotic non-alcoholic steatohepatitis (NASH) displaying moderate-to-advanced liver scarring (fibrosis). This medication is intended for use in conjunction with dietary adjustments and regular exercise. Clinical trial The FDA approval is based on the safety and efficacy outcomes assessed in a 54-month study using a surrogate endpoint to measure liver inflammation and scarring.
The study involved 888 participants with noncirrhotic NASH and moderate to advanced liver scarring, randomly assigned to receive either placebo or different doses of resmetirom in addition to standard NASH care. Results at 12 months showed that 26% to 36% of participants taking resmetirom experienced NASH resolution with no deterioration in liver scarring, compared to 9% to 13% of individuals receiving…
