FDA Greenlights Non-Invasive FibroScan for MASH Developments
Advancements in Liver Health: FibroScan's Milestone
This milestone opens a path for FibroScan to ultimately replace liver biopsy for patient enrollment and treatment response assessment in metabolic dysfunction-associated steatohepatitis (MASH) drug development.
FDA Acceptance: A New Era for MASH Trials
Echosens is excited to announce that the U.S. Food and Drug Administration's Center for Drug Evaluation and Research (CDER) has accepted a Letter of Intent for the qualification of Liver Stiffness Measurement by Vibration-Controlled Transient Elastography (FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH.
This marks a significant milestone as it is the first occasion the FDA is initiating the qualification process for a non-invasive test in the drug development landscape for MASH—a type of liver disease that can cause severe health issues, including liver cancer.
The Significance of This Acceptance
This acceptance signals a major shift toward incorporating non-invasive testing in drug development protocols. According to Frank Anania, MD, this is an important step for the adoption of non-invasive tests in MASH treatment development.
Replacing Traditional Biopsies
Currently, repeated liver biopsies are regularly needed to assess patient responses and enroll patients in trials. FibroScan provides a convenient alternative. The exam is quick, painless, and can be repeated frequently, offering a thorough overview of liver health.
Expert Opinions on FibroScan’s Qualification
Dr. Arun Sanyal from the Stravitz-Sanyal Institute emphasizes the milestone's significance, attributing it to years of dedicated clinical research. He believes this breakthrough will accelerate drug development and ease the transition into clinical practice.
Global Recognition of FibroScan’s Effectiveness
FibroScan's remarkable clinical validation and extensive use in pharmaceutical trials spotlight its role as a leading non-invasive solution for liver health. Supported by over 5,600 peer-reviewed publications, FibroScan stands out in the industry.
Its clinical outcomes have been showcased in key medical journals and are recognized by numerous pharmaceutical companies and biotechs conducting MASH trials. Echosens's proposal to the FDA was bolstered by support letters from significant entities in the sectors involved.
Implications for Pharmaceutical Development
The acceptance of FibroScan as a surrogate endpoint is transformative, offering a way to improve trial enrollment and patient retention. It is anticipated to hasten the pathway to new therapies while allowing researchers to design trials that are safer and more representative.
A Bright Future for Non-Invasive Testing
With the growing recommendation for FibroScan from key clinical guidelines and payer policies, this acceptance reinforces FibroScan's establishment as the reference non-invasive test for MASH treatment monitoring.
This achievement also reflects Echosens’s leadership and commitment to innovation. The recent launch of Guided VCTE technology in the latest FibroScan devices enhances the efficacy, automation, and standardization of liver scanning.
About Echosens
Echosens is a pioneer in liver health assessment. With FibroScan, they have revolutionized non-invasive solutions for liver management. Their technology is globally recognized and validated, with applications across numerous countries and millions of examinations conducted.
Frequently Asked Questions
What is the significance of the FDA accepting FibroScan?
The FDA's acceptance marks the potential for FibroScan to serve as a surrogate endpoint in MASH trials, which could transform drug development processes.
How does FibroScan compare to traditional liver biopsies?
FibroScan is a quick, painless, and non-invasive alternative to liver biopsies, providing comprehensive liver health assessments with no recovery time required.
What does the acceptance mean for patients with MASH?
Patients may benefit from reduced need for biopsies and a more streamlined process in clinical trials, potentially leading to faster access to new therapies.
Who supports the use of FibroScan in clinical trials?
FibroScan has received endorsements from several pharmaceutical companies, including Eli Lilly and Novo Nordisk, reflecting its credibility and effectiveness in trials.
Where are FibroScan services available?
FibroScan technology is available across more than 127 countries, making it accessible to millions of patients needing liver health assessments.
About The Author
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