#USA #FDA Approval #Echosens #FibroScan #Westborough

FDA Embraces Non-Invasive Liver Diagnostics

Echosens, a leading innovator in non-invasive liver diagnostics, has recently reached a significant milestone. The U.S. Food and Drug Administration (FDA) has accepted the company's letter of intent to qualify Liver Stiffness Measurement (LSM) via Vibration Controlled Transient Elastography (FibroScan®) as a probable surrogate endpoint in clinical studies focused on Metabolic Dysfunction-Associated Steatohapatitis (MASH). This groundbreaking acceptance marks the first time the FDA has initiated the qualification process for a non-invasive test as a surrogate endpoint in the drug development pathway for MASH.

MASH poses serious health risks, including cirrhosis, liver cancer, liver transplantation, or even death. The FDA's announcement, conveyed by Dr. Frank Anania, MD, director of hepatology at the FDA's Center for Drug Evaluation and Research (CDER), signifies a pivotal move towards integrated non-invasive testing in the drug development process for MASH.

Significance of LSM by VCTE in MASH

As indicated in the letter of intent, LSM provided by FibroScan® can reliably predict the overall mortality risk or liver-related events in patients suffering from MASH. The reception of this letter means that FibroScan® will potentially replace liver biopsy as the primary endpoint in interim analyses for accelerated approval studies concerning adults with non-cirrhotic MASH. The switch from traditional liver biopsies, which can be invasive and painful, to the quick, painless FibroScan® procedure represents a substantial benefit for patients. A FibroScan® examination takes only a few minutes and yields a comprehensive assessment of liver health that can be performed as frequently as necessary.

According to Dr. Arun Sanyal, MD, a prominent figure in liver disease research, the acceptance of this intent letter is a significant milestone rooted in years of clinical research and collaborative efforts across the field. He expressed optimism that this new approach will fast-track drug development and facilitate easier clinical implementation.

Clinical Validation and Industry Support

This unprecedented acceptance by the FDA derives from the robust clinical validation supporting FibroScan® as the leading non-invasive liver health solution globally. More than 5,600 expert-reviewed publications endorse this technology, including pivotal studies demonstrating a correlation between changes in LSM and liver-related outcomes. FibroScan® is already recognized as a non-invasive reference test by all major pharmaceutical companies conducting MASH studies, with support letters from industry giants like Eli Lilly, Boehringer Ingelheim, and Novo Nordisk included in the application submitted to the FDA.

The adoption of FibroScan® as a probable surrogate endpoint holds the potential to revolutionize the drug development landscape for MASH, as it can enhance the recruitment and retention of patients in clinical trials. This development could expedite the pathway to new therapies, allowing researchers to design safer, more representative, and efficient studies. Professor Quentin Anstee of the University of Newcastle highlighted the critical function of non-invasive tests in clinical MASH studies, reinforcing the message that pharmaceutical sponsors must incorporate robust non-invasive biomarker data in ongoing and future trials.

Future Directions

In addition to its existing stronghold in prominent clinical guidelines and preferred status in payer policies, the FDA's acceptance of this letter of intent further consolidates FibroScan®'s standing as a non-invasive reference tool for prescribing and monitoring treatments for MASH, both approved and in development. This notable achievement also underscores Echosens' leadership and ongoing innovation in the field, recently enhanced with guided VCTE technology in the latest generation of FibroScan® devices, which aim for greater efficiency, automation, and standardization in liver assessment.

As a pioneer in its area, Echosens has revolutionized the practice of liver health assessment with FibroScan®. The tool is acknowledged worldwide and validated by over 5,600 expert studies, including nearly 220 international guidelines. The reach of FibroScan® has expanded to more than 127 countries, facilitating millions of liver assessments globally.

For more information on Echosens and FibroScan®, visit their official website at Echosens.com.