A New Era in MASH Treatment: How FibroScan^® Supports Patient Care

Rezdiffra™ is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).

• This indication is approved under accelerated approval based on improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

• Limitation of use: Avoid use in patients with decompensated cirrhosis.

Wegovy^® (semaglutide) injection 2.4 mg is indicated, in combination with a reduced calorie diet and increased physical activity, for:

• Treatment of adults with noncirrhotic MASH with moderate to advanced fibrosis (F2–F3). The indication for MASH is approved under accelerated approval based on the improvement of MASH and fibrosis. Continued approval for this indication may be contingent upon the verification and description of clinical benefit in a confirmatory trial.

• Risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight.

• Reduction of excess body weight and maintenance of weight reduction long term in adults and pediatric patients aged 12 years and older with obesity and adults with overweight in the presence of at least one weight-related comorbidity.

• Limitations of use: Wegovy^® contains semaglutide. Coadministration with other semaglutide-containing products or with any GLP-1 receptor agonist is not recommended.

Please see full prescribing information for Rezdiffra™ and Wegovy^®.

Identify patients at risk: Non-invasive, point-of-care exams take just a few minutes.   Risk stratify with objective data: FibroScan® provides quantitative measurements of steatosis (CAP score) and fibrosis (LSM by VCTE™), which help confirm diagnosis and guide treatment decisions.   Support treatment initiation: Objective FibroScan® results provide confirmation of diagnosis, which payers require for medical necessity and prior authorization.   Monitor treatment response: FibroScan® makes it simple to track improvements in liver fat and stiffness over time, giving providers, patients, and payers tangible evidence of improvement.

FibroScan^® is widely adopted in clinical practice and has been instrumental in the pivotal trials that led to the recent FDA approvals for MASH therapies.

• In Novo Nordisk’s ongoing ESSENCE trial, FibroScan^® is a key non-invasive tool (NIT). It was used to screen patients for enrollment and to measure secondary endpoints related to NITs. At 72 weeks, patients showed improvements in both CAP score (a measure of steatosis) and LSM by VCTE™ (an assessment of fibrosis) compared to placebo.

• In Madrigal’s MAESTRO-NASH Phase 3 trial, the proprietary biomarkers of FibroScan^® (LSM by VCTE™ and CAP) played a key role. These measurements were crucial for patient prescreening and provided accurate, non-invasive assessment of therapeutic response after 52 weeks.

MASH affects approximately 1 in 20 adults¹, yet 9 out of 10 people² living with it remain undiagnosed.

Without intervention, MASH can progress to cirrhosis, liver failure, and higher risk of cardiovascular events and type 2 diabetes.

Expanding access to scalable, validated, and cost-effective NITs like FibroScan^® is critical to closing the diagnosis gap and connecting patients with timely care.

Discover how FibroScan^® can support diagnosis, streamline documentation, and help your team monitor patient response to new MASH therapies.

1. Younossi ZM et al., Hepatology, 2023.
2. Schattenberg JM et al., Liver International, 2021.