CONSHOHOCKEN, PA — Madrigal Pharmaceuticals, Inc. (NASDAQ: MDGL) has revealed promising patient-reported outcomes showing that Rezdiffra (resmetirom) significantly enhances health-related quality of life (HRQL) for individuals with nonalcoholic steatohepatitis (NASH) with moderate to advanced fibrosis. These findings were recently published in the journal Hepatology.
Rezdiffra, a once-daily oral medication targeting the liver, is the first of its kind approved by the FDA for NASH treatment. It is designed to address the core causes of NASH by acting as a thyroid hormone receptor-β agonist. The Phase 3 MAESTRO-NASH biopsy trial demonstrated that Rezdiffra effectively improved fibrosis and resolved NASH symptoms, with 80% of participants showing improvement or stabilization of fibrosis when taking the 100 mg dose.
Dr. Zobair M. Younossi, a leading expert in liver disease and the study’s primary author, emphasized the impact of NASH on patients’ lives: “The serious burden of NASH on patient quality of life remains poorly understood and underappreciated by the health system…these results demonstrating that Rezdiffra helped patients achieve clinically meaningful and statistically significant improvements in multiple domains of HRQL are highly encouraging.” He also noted that the study found no negative impact on HRQL due to Rezdiffra’s side effects, highlighting the drug’s tolerability.
Throughout the study, patients’ HRQL scores improved over time, particularly in areas such as Worry, Health Distress, and Stigma, among those receiving Rezdiffra compared to placebo recipients. Notably, patients responding to treatment with Rezdiffra showed greater improvements than those who did not receive the drug, especially those with more severe fibrosis at the start of the trial.
Bill Sibold, CEO of Madrigal, spoke on the broader implications of these findings: “NASH is the leading cause of liver transplant among women and those who get listed for hepatocellular carcinoma in the U.S… The introduction of Rezdiffra as the first FDA-approved therapy for NASH has provided hope for patients, and we see this demonstrated in the improvements in health-related quality of life observed in the MAESTRO-NASH trial.”
As ongoing confirmatory trials continue, Rezdiffra’s initial approval remains contingent upon further evidence of clinical benefit. Nonetheless, these results offer a promising prospect for those affected by NASH, underscoring the therapy’s potential to improve patient lives significantly.
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