In a monumental moment in the never-ending pursuit of putting a major dent in Fatty Liver disease, Madrigal Pharmaceuticals announced positive topline results from the pivotal Phase 3 MAESTRO-NASH clinical trial of resmetirom for the treatment of NASH and liver fibrosis. Madrigal’s leadership intends to file for resmetirom’s accelerated approval with the FDA in the first half of 2023. If approved, the drug may become the first NASH medication introduced to market, depending on the outcome and timing of Intercept Pharmaceuticals’ refiling of obeticholic acid.
To recognize this special occasion, Surfing the NASH Tsunami hosts its largest ever suite of panelists who react to the enthusiasm, synergy and implications surrounding the news. This first conversation from the series incorporates highlights of our exclusive discussion with Donna Cryer, Founder and CEO of the Global Liver Institute. Donna focuses her initial comments around the MAESTRO-NASH data and the ways it benefits the overall field and demonstrates sustainability for NASH therapy as a whole. She extends her notes to consider the breadth of the Madrigal program and its implications for the full range of patients. Another consideration explores the program’s impact on practical use of NITs in demonstrating value in patient management and to the various stakeholders interested in building integrated systems. As Roger describes, this conversation is “pulling on all threads” of what these results and this energetic moment mean for sustainability in the field. This is a rich dialogue with many more notes and insights on how this story develops our understanding of where the liver fits in both the biological system and what efforts are required to integrate healthcare systems with timely, seamless adoption.