FDA's Acceptance of Intent Letter Transforms Non-Invasive Liver Assessment with FibroScan®

Significant Milestone for Non-Invasive Liver Diagnostics

Echosens, a leading player in non-invasive liver diagnostics, has achieved a groundbreaking milestone with the acceptance of their intent letter by the Center for Drug Evaluation and Research (CDER) of the FDA. This development qualifies the measurement of liver stiffness via Controlled Attenuation Parameter (FibroScan®) as the first non-invasive surrogate endpoint in clinical studies for Metabolic Associated Steatotic Liver Disease (MASH).

A Transformative Shift in Clinical Practices

For the first time, the FDA has initiated the qualification process for a non-invasive test to be considered a reasonable surrogate endpoint in drug development for MASH. This progressive condition can escalate to severe outcomes such as cirrhosis, liver cancer, and even death. Dr. Frank Anania, director of the Hepatology and Nutrition Division at the CDER, emphasized that this proposal signifies an essential shift towards incorporating non-invasive tests in drug development methodologies.

Understanding FibroScan®'s Role

FibroScan® utilizes advanced technology to measure liver stiffness (LSM) through a quick, painless procedure, which can efficiently predict the risk of overall mortality and liver-related events in patients with MASH. With the acceptance of the intent letter, FibroScan® is poised to replace liver biopsies as the primary endpoint in clinical trials assessing therapies for adults suffering from non-cirrhotic MASH. This move would alleviate the burden on patients currently subjected to multiple invasive biopsies.

According to Arun Sanyal, a professor and director at the Stravitz-Sanyal Institute for Liver Disease and Metabolic Health, this acceptance is a substantial achievement resulting from years of clinical research and extensive collaboration across various industry stakeholders. It is expected to hasten drug development processes and seamlessly integrate into clinical practice.

Clinical Validation and Global Recognition

The unprecedented acceptance of the intent letter is attributed to the unparalleled clinical validation of FibroScan® and its substantial application in critical pharmaceutical trials related to liver diseases, especially MASH. Globally recognized as the leading non-invasive solution for liver health, FibroScan® is supported by over 5,600 peer-reviewed publications, shedding light on its efficacy. Noteworthy studies, such as those in the Journal of Hepatology and JAMA, have linked alterations in LSM measurements via FibroScan® to pertinent liver outcomes.

Major pharmaceutical and biotechnology firms have already adopted FibroScan® as their non-invasive reference standard for point-of-care assessments in MASH studies, with support letters from industry giants like Eli Lilly and Novo Nordisk fortified the FDA request.

Implications for Pharmaceutical Companies

The FDA’s acknowledgment of FibroScan® as a reasonable surrogate endpoint could transform pharmaceutical development for MASH. Improved patient recruitment and retention in drug trials could accelerate the innovation pathway for new therapies. Professor Quentin Anstee from Newcastle University hailed this letter of intent’s acceptance as a foundational step toward the practical adoption of non-invasive tests as surrogate endpoints in MASH clinical studies. This is a clear message for pharmaceuticals to gather reliable biomarker data in ongoing and future MASH clinical trials.

Adding to existing recommendations for FibroScan® from leading guidelines and its favorable positioning in payer policies, the FDA's acceptance fortifies FibroScan®'s role as the gold standard for prescribing and monitoring treatments for MASH. Furthermore, this achievement highlights Echosens' continuous leadership and innovation as they enhance FibroScan® technology with Guided VCTE in their latest devices, improving efficiency and standardization in liver scanning for healthcare professionals.

Conclusion

Echosens is at the forefront of revolutionizing liver health assessment with FibroScan®, a non-invasive tool that has garnered recognition worldwide. Available in over 127 countries, FibroScan® has facilitated millions of liver examinations globally. This recent FDA milestone represents a significant stride not just for Echosens but for the broader healthcare landscape, potentially changing how liver diseases are diagnosed and treated.