In the early hours of March 15, 2024, the United States Food and Drug Administration (FDA) has expedited the approval of Rezdiffra (Resmetirom) to be used in conjunction with diet and exercise for the treatment of adults with non-cirrhotic NASH with mid to late-stage liver fibrosis (meeting F2 to F3 fibrosis), becoming the first NASH drug to be approved by the FDA in 40 years.
NASH, also known as MASH, was officially renamed at the 2023 European Association for the Study of the Liver (EASL) conference, as per the consensus of experts. According to the Global Liver Institute, it is estimated that by 2030, 357 million people worldwide will be affected by MASH. Data from Frost & Sullivan indicate that the global MASH drug market is expected to reach $10.7 billion by 2025 and will grow to $32.2 billion by 2030.