Rochester, MN – Resoundant, a Mayo Clinic company and the developer of Magnetic Resonance Elastography (MRE), is thrilled to announce the U.S. Food and Drug Administration (FDA)'s approval of Resmetirom (Rezdiffra™). This groundbreaking treatment offers new hope for patients with Metabolic-dysfunction Associated Steatotic Liver Disease (MASLD) and Metabolic-dysfunction Associated Steatohepatitis (MASH), marking a significant advancement in the battle against these challenging conditions.
Michael Kalutkiewicz, Vice President of Global Policy for Resoundant, Inc., expressed his optimism regarding the impact of Resmetirom: "The approval of Resmetirom represents a pivotal moment for the MASLD and MASH patient community. We are optimistic that Resmetirom will emerge as a powerful therapy for these patients. The MRI community is excited and fully committed to supporting this important patient population, leveraging our expertise and technologies to ensure accurate diagnoses and expand patient access to this novel treatment."
In the groundbreaking MAESTRO-NASH trial by Resmetirom developer Madrigal Pharmaceuticals, Resmetirom had a significant treatment effect on both liver fibrosis via MRE and liver fat MRI-PDFF. Demonstrating the potential for Resmetirom to improve patient health, the drug doubled the number of patients who had improvements in liver fibrosis via MRE, while halving the number of patients whose fibrosis worsened. In terms of reducing liver fat, over half of patients showed a significant reduction over the 52-week course of the study. Out of all the biomarkers assessed by Madrigal, only MRI-PDFF resolution correlated with subsequent reductions in liver fibrosis – indicating its future role in monitoring therapy response moving forward.
Resmetirom's approval now underscores the importance of accurate diagnosis and expanding patient access to effective treatments. In this regard, low-cost, rapid MRI will no doubt play a pivotal role. MRE and MRI-PDFF are well-validated and widely available noninvasive diagnostics for MASLD and MASH with fibrosis. These technologies are not only widely accessible across over 1,300 locations in the United States (surpassing ~800 Fibroscan™ locations), but they also offer a low-cost, efficient alternative to liver biopsy, requiring less than 10 minutes per exam for ~$200 under Medicare. Unlike ultrasound methods, MRI is not confounded by high BMI, has a higher technical success rate, and has a low coefficient of variance compared to ultrasound methods (19% vs ~35%). It also has a significantly higher positive predictive value for correctly ruling-in patients who might be candidates for Resmetirom treatment – notably those who have mild to moderate fibrosis (F1-F3) with moderate to severe liver fat (S2-S3).
As clinicians and patients consider the integration of Resmetirom into treatment regimens, the utilization of MRI-PDFF and MRE is poised to significantly enhance patient accessibility. These imaging techniques offer a detailed portrayal of liver health, which aids healthcare providers in determining a patient's suitability for Resmetirom therapy and tracking the treatment's efficacy over time.
About MRE
MR Elastography was invented at Mayo Clinic. It is widely available to clinicians at over 2,500 locations across the globe and is the most accurate MRI technology for staging liver fibrosis. Clinicians and patients can find U.S. locations at MRE:connect (www.resoundant.com/mre-connect). The role of MRE has been increasingly recognized in multidisciplinary clinical guidelines for routine liver fibrosis assessment, particularly in suspected cases of Metabolic-dysfunction Associated Steatohepatitis Liver Disease (MASLD) and Metabolic-dysfunction Associated Steatohepatitis (MASH). The American College of Radiology’s Appropriateness Criteria identifies MRE as the most accurate and applicable noninvasive liver fibrosis exam. MRE is reimbursed via a Category I CPT® code (76391) and is covered by most public and private insurance plans.
About Resoundant
Resoundant is a Mayo Clinic company dedicated to the development and promotion of Magnetic Resonance Elastography (MRE) technology. Founded on the principles of innovation, excellence, and patient-centered imaging, Resoundant is committed to improving the diagnosis and management of liver diseases and other health conditions, thereby enhancing patient care and outcomes.
For more information, go to http://www.resoundant.com
Contact:
Michael Kalutkiewicz
Vice President of Global Policy
+1 507-322-0011
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Please note: This press release is for informational purposes only and should not be considered medical advice. Patients should consult their healthcare provider for more information about Resmetirom and its suitability for their condition.
