On March 14, 2024, The Us Food and Drug Administration (FDA) Made History when it grants Accelerated Approval to Madrigal Pharmaceuticals’ Resmetirom (Rezdiffra), Making It the First and Only Treatment for Noncirrhotic Nonalcoholic Steatohepatitis (Nash), Now Known As Steatohepatitis associated with metabolic dysfunction (puree).
A year later, the impact of Resmetirom on clinical practice and patient care continues to evolve. In recognition of the anniversary of the historic decision, the last HCPLIVE RX review highlights a conversation between a trio of experts in the matter reflecting on the last year of Resmirom as an option of treatment for patients, remaining the unsatisfied needs in mash management and the evolution of the therapeutic pipeline ready to further transform care.
Estimated to affect more than 30% of the world’s population, Masld is the most common chronic hepatic disease in the world. Mash represents an advanced Masld stage and has historically failed in treatment options beyond lifestyle changes with food and exercise. In the absence of pharmacological therapies, weight loss served as the cornerstone of disease management.
This changed in March 2024, when Resmetirom became the first and only puree approved by the FDA, gaining accelerated approval for the treatment of non -cirrhotic puree with moderate to advance fibrosis. Although lifestyle interventions continue to play a central role in puree care, because the selective agonist of the thyroid hormone receptor is indicated jointly with food and exercise, they are no longer the only tools available for disease management.
In the fifth segment of our 6 games HCPLIVE RX review On the occasion of the one-year anniversary of the approval of the FDA of Resumetirom and the evolutionary landscape of the management of the puree, the moderator Jeff McIntyre raises the subject of the diagnoses and non-invasive biomarkers, emphasizing their potential role beyond screening and diagnosis, in particular for the monitoring of patients. He continues by asking the Panelists Mazen Noureddin, MD, MHSC and Juan Pablo Arab, MD, on how the progress of non -invasive tools shape patient selection, disease monitoring and future treatment strategies.
Arab underlines that non -invasive methods are the future. Although hepatic biopsy remains precious, imaging techniques such as transient elastography and MRI-PDFF, as well as serum tests such as ELF, offer promising alternatives. It highlights the use of simple tools like FIB-4 combined with transient elastography to effectively stratify the risk in the large population affected by a steatotic hepatic disease.
Noureddin agrees that current non -invasive tools are effective but notes the need for additional refinement. Efforts are underway to rationalize the diagnosis, in particular automatic learning models and advanced biomarkers to replace the current approach in two stages recommended by the guidelines by FIB-4 and transitional or ELF elastography.
He underlines research showing that non -invasive scores predict liver results and are correlated with clinical improvements – the key for regulatory approval. A next main step is to eliminate the biopsy of clinical trials, with work in progress to provide regulators with the necessary evidence.
Moderator::
Jeff McIntyre is vice-president of liver health programs to the Global Liver Institute.
Pandilists:
Mazen Noureddin, MD, MHSC, is professor of medicine and hepatologist of transplantation at Houston Methodist and director of the Houston Research Institute.
Juan Pablo Arab, MD, is an associate professor of medicine at the gastroenterology, hepatology and nutrition division at Virginia Commonwealth University School of Medicine
Noureddin has relevant disclosure with Altimmun and Madrigal, Merck, Takeda, Sterns and others. Arab and McIntyre have no relevant disclosure.
References:
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American food and drug administration. The FDA approves the first treatment for patients with liver scars due to a fatty liver disease. March 14, 2024. Accessed March 13, 2025. https://www.fda.gov/news-events/press-announces/fda-approves-first-treat–puits-liver-carring-due-fatty-liver-dionatist
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Brooks, A. Stephen Harrison, MD: promising phase 3 data for the resmetirom in Nash, fibrosis. HCPLIVE. February 7, 2024. Accessed March 13, 2025. https://www.hcplive.com/view/stephen-harrison-md-promis-phase-3-data-resmetirom-nash-fibrose.