Resmetirom, a thyroid hormone receptor beta-selective agonist, is the first FDA-approved medication for MASH with moderate to advanced liver fibrosis.
The US Food and Drug Administration has approved resmetirom , the first drug to treat patients with metabolic dysfunction–associated steatohepatitis and moderate to advanced liver fibrosis , along with diet and exercise.
The approval is based on the phase 3 MAESTRO-NASH trial, in which resmetirom was superior to placebo at achieving resolution ofdisease . An international consensus group has since changed these terms to MASH and metabolic dysfunction–associated steatotic liver disease , respectively.
Patients were followed for 52 weeks, at which point, they were assessed for the dual primary endpoints of NASH resolution with no worsening of fibrosis and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score.At 52 weeks, NASH resolution with no worsening of fibrosis was achieved in 25.9% and 29.9% of the patients in the 80-mg and 100-mg groups, respectively, compared with 9.7% on placebo.
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