FibroScan®
The EC approval of Rezdiffra™ (resmetirom) was announced on August 19, 2025. Can you provide some background and share why this is such an important milestone?
Prof. Dr. Schattenberg: Based on the positive results in the MAESTRO-NASH trial, we’ve seen a positive evaluation of EMA regarding the use of resmetirom in non-cirrhotic patients with advanced metabolic dysfunction-associated steatohepatitis (MASH). This is clearly a watershed moment for the field and marks the first time that a drug is approved for the indication of MASH. The EMA recommendation sets the scene for the drug to become available in Germany, hopefully within the next weeks, and is very clearly one of the outstanding moments for not only patients, but also physicians.
Looking ahead to the next 12 to 24 months, what gaps could resmetirom help fill and for whom?
Prof. Dr. Schattenberg: In the next 12 to 24 months, we will see more granular data emerge on the changes in non-invasive tests (NITs) and additional safety data; long-term safety data is crucial for us to advise patients and also monitor the treatment response and give recommendations on which patients should be treated. Likewise, to identify patients who are not responding adequately. And as such, I’m very excited about the next one or two years moving forward, again, collecting data as the trials continue, but also in real life. And I want to share with you that the German SLD registry is ready to capture the data and contribute to the globally growing real-world data set of patients that are being treated with resmetirom.
How can NITS help breed confidence among providers to prescribe treatment and support their patients’ adherence to treatment over time?
Prof. Dr. Schattenberg: One of the important aspects of this approval is that the regulators have accepted the clinical reality, which means we’re not using liver biopsy to diagnose and monitor patients. In clinical practice, we’re using NITs based on what we’ve been developing in the field over the last decade. And these tests are precise enough to identify patients, monitor patients, and also predict outcomes. Moving forward, NITs will be the pillar of managing patients with metabolic dysfunction-associated steatotic liver disease.
Why are non-invasive tests like FibroScan® critical to identify and monitor patients for this treatment?
Prof. Dr. Schattenberg: FibroScan® was developed some time ago, and we have developed a clinical understanding of the value of this non-invasive test. FibroScan® is used to assess disease severity and helps clinicians to grade the disease stage. The absolute strength of this test is to categorize patients into risk categories and advise on the management.
Germany is expected to be the first EU country to gain access. What’s your “year-one playbook”?
Prof. Dr. Schattenberg: I expect recommendations of the national German gastroenterologist organization, DGVS, to be released at the time of the annual meeting in Leipzig in September. These guidelines will provide recommendations on thresholds and allow for the assessment of treatment response for patients with MASH. I expect a consensus statement that frames the treatment based on the label of resmetirom.
Looking ahead a few years, how do you see the treatment landscape for MASH evolving now that we have the first therapy in the EU, and what role will early detection and NITs play in that evolution?
Prof. Dr. Schattenberg: That’s a very exciting question, and I am optimistic that it will also be a good story to tell. After the approval, we will see the combined use of approved drugs with broad metabolic actions and resmetirom, and this will benefit the patient with liver disease and a metabolic risk profile. Certain combinations that were not allowed in clinical trials, for example, initiating a GLP-1-based therapy for a non-liver indication, let’s say for obesity or diabetes, and the addition of anti-fibrotic treatment for MASH, should play out well. And the NITs are obviously the tests that will allow us to monitor these patients in real-time, assessing the combined treatment response and safety.
Additionally, for the approval of resmetirom, the label, as it reads today—it is very important to not treat patients with cirrhotic disease. An absolute strength of NITs, including FibroScan®, is to rule out advanced liver disease stages. In particular, the categorical changes—movements by five kilopascal categories or more will help us to discuss the long-term prognosis with patients.
How do you see primary care physicians fitting into the use of resmetirom and referral pathways for liver care?
Prof. Dr. Schattenberg: I think the intersection of specialists and primary care working together is one of the crucial aspects of providing liver care. Most of our patients with liver disease are in primary care. Very few are actually seen in a hepatologist’s office—there are many more in the endocrinologist’s office. Based on the public healthcare system in Germany and the tendency to put high-priced medication into experts‘ hands, I would not see the initial use of resmetirom in a primary care office at first.
Now, this could be a totally different story for the use of NITs to identify patients in primary care and to be referred to a specialist who then details the indication to treat liver disease. With increasing knowledge about the novel drug, and in the future, I do see that an indication that was confirmed and a drug that was prescribed once could potentially be followed up and refilled in a primary care office.
LSM by VCTE, FibroScan’s proprietary, clinically validated technology, was highlighted in Madrigal’s press release and used repeatedly in the MAESTRO-NASH trial. What role do you see FibroScan’s LSM by VCTE playing in identifying and monitoring patients for treatment?
Prof. Dr. Schattenberg: The phase three pivotal trial, the MAESTRO-NASH trial, has generated ample evidence on the efficacy of the drug, but also on the diagnostics involved. VCTE is among the tests that have been used repeatedly in the trial. So we’ll learn a lot about the meaning of changes of VCTE in relation to treatment response. And if you think of the current AASLD recommendations on how to use the drug, VCTE is anchored in there within these recommendations.
Now, this can be supported by additional blood-based biomarkers in the future, too. The incremental gain in knowledge on the use of NITs through those pivotal trials will help the affected patients seen in clinical practice. And again, the important message is that those trials are ongoing, and we will be collecting data in the real world through registries.
