LSM

FDA Accepts Liver Stiffness Measurement ‍as Surrogate Endpoint,Accelerating MASH Drug Development

Washington D.C. – In a landmark decision‌ poised to ⁣dramatically accelerate the development of ⁣treatments for metabolic-associated‍ steatohepatitis​ (MASH), ‍formerly known as NASH, the Food and Drug ⁢Administration ​(FDA) has accepted⁢ liver stiffness measurement‌ (LSM) by Vibration Controlled Transient Elastography (VCTE) as a surrogate endpoint⁢ for clinical benefit. This change, announced recently,⁢ streamlines the pathway for drug approvals in MASH, a condition affecting millions wiht no currently approved pharmaceutical therapies.

Previously, MASH drug⁤ trials ​required lengthy and ⁢costly ⁣studies ⁣tracking histological⁤ improvements – examining liver‌ tissue biopsies‌ – to demonstrate efficacy. The FDA’s​ acceptance of LSM by VCTE, a non-invasive method of assessing‌ liver⁢ fibrosis, significantly reduces the time ⁣and resources needed for clinical trials, potentially bringing effective treatments to patients faster. This decision‍ impacts pharmaceutical companies currently ⁢developing MASH therapies, and also the estimated 1.5‌ million Americans and millions more worldwide affected ‍by the disease.The acceptance of LSM by VCTE builds on growing evidence demonstrating its correlation with ⁣long-term clinical outcomes, including‍ liver-related events⁣ and⁢ mortality. Several⁤ key trials⁣ are already utilizing ‌the ⁢endpoint, including ⁣Madrigal Pharmaceuticals’ SYNCHRONY-Outcomes trial of⁢ efruxifermin and 89bio’s ⁣ENLIGHTEN-Cirrhosis trial of pegozafermin. Additionally,‌ LSM by VCTE is ⁢being ‌employed in alcohol-related liver disease (ALD) trials, such as GSK’s Phase II STARLIGHT trial of GSK4532990 and Altimmune’s Phase II RESTORE trial of pemvidutide. ‌

According to Jay Patel, a Pharma analyst with GlobalData, the FDA’s decision ⁣”consolidates Echosens’ position‌ as the leading non-invasive‌ diagnostic manufacturer ‍in‌ the MASH ⁢space⁤ and opened‌ the ‌door⁤ for faster approval of a wider ⁤range‍ of drugs to meet the unmet‌ need in this growing disease.”‌ Echosens‌ recently launched its Guided VCTE technology, further⁤ streamlining ⁤the assessment process.

The⁣ shift is expected to ‌encourage increased ⁣investment ​and ​innovation in MASH ⁢drug development, offering hope for patients⁢ facing a condition that can progress to ⁤cirrhosis, liver failure, ‍and‌ the need for transplantation.