Resmetirom FDA Label: Approved Dosing for NASH F2-F3
Resmetirom (Rezdiffra) is FDA-approved for noncirrhotic NASH with F2-F3 fibrosis at 80mg or 100mg daily by weight. See MAESTRO-NASH results and dosing details.
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Resmetirom (Rezdiffra) is FDA-approved for noncirrhotic NASH with F2-F3 fibrosis at 80mg or 100mg daily by weight. See MAESTRO-NASH results and dosing details.
Is resmetirom effective for NAFLD without MASH? Review of clinical trial data, FDA-approved indications, off-label evidence, and what clinicians should know about prescribing Rezdiffra beyond its labeled use.
Resmetirom (Rezdiffra) is FDA-approved for MASH with fibrosis, not NAFLD broadly. Learn the off-label evidence, required lab monitoring, and clinical considerations for using resmetirom in NAFLD without significant fibrosis.
Resmetirom (Rezdiffra) received accelerated FDA approval for MASH with F2-F3 fibrosis in 2024. Review the MAESTRO-NASH trial data, side-effect profile, monitoring requirements, and clinical tradeoffs before starting treatment.
MAESTRO-NASH data: resmetirom 100mg resolved NASH in 29.9% vs 9.7% placebo at 52 weeks; FDA-approved, not off-label, for F2-F3 fibrosis.
MAESTRO-NASH: 26% on 100mg resmetirom achieved NASH resolution vs 10% placebo at 52 weeks. See dosing, monitoring labs, and imaging schedule for F2-F3 fibrosis.