First Drug Approved in US for Severe Fatty Liver Disease

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The US Food and Drug Administration (FDA) granted approval on Thursday to Madrigal Pharmaceuticals' Rezdiffra, marking a significant milestone as the first medication sanctioned for individuals suffering from a severe type of non-alcoholic fatty liver disease (NAFLD).

Clinical trials involving hundreds of participants with non-alcoholic steatohepatitis (NASH), the most severe manifestation of NAFLD characterized by liver scarring due to fat accumulation, demonstrated Rezdiffra's efficacy in improving liver scarring.

Nikolay Nikolov of the FDA emphasized the groundbreaking nature of this approval, stating that prior to Rezdiffra, patients with NASH and significant liver scarring lacked a medication capable of directly addressing their liver damage. The approval now offers a treatment option alongside dietary and exercise regimens.

NASH, affecting approximately 6-8 million Americans, often coexists with other health complications such as high blood pressure, type 2 diabetes, obesity, and elevated blood fat levels. Symptoms may include weakness, fatigue, jaundice, spider-like blood vessels, and more. If left untreated, NASH can progress to cirrhosis, ultimately leading to liver failure and necessitating a transplant.

Rezdiffra, also known as resmetirom, operates as an oral medication targeting the root causes of NASH. In a comprehensive trial involving 966 participants, Rezdiffra exhibited promising outcomes, with liver biopsies at the 12-month mark indicating a higher proportion of individuals achieving resolution or improvement of their condition compared to those who received a placebo. The findings were published in February in the New England Journal of Medicine.

However, Rezdiffra is not without side effects, with reported instances of diarrhea and nausea among users.

Madrigal CEO Bill Sibold acknowledged the extensive research and development efforts spanning over 15 years that culminated in the accelerated approval of Rezdiffra. The American Liver Foundation's Lorraine Stiehl commended the approval as a groundbreaking advancement in the treatment landscape for NASH.

Madrigal Pharmaceuticals anticipates making Rezdiffra available to patients in the United States by April, marking a significant step forward in addressing the unmet medical needs of individuals grappling with severe forms of NAFLD.

March 15, 2024 1:50 p.m. 14787

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