FDA accepts Madrigal’s liver disease therapy NDA for review

14 Sep 2023
www.pharmaceutical-technology.com
Priority ReviewPhase 2NDAPhase 3
FDA accepts Madrigal’s liver disease therapy NDA for review
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Source: Pharmaceutical Technology
Resmetirom will target crucial underlying causes of NASH in the liver. Credit: crystal light / Shutterstock.com.
The US Food and Drug Administration (FDA) has accepted for review Madrigal Pharmaceuticals’s new drug application (NDA) for resmeritom, a liver disease therapy.
Resmetirom is indicated for treating adult patients with nonalcoholic steatohepatitis (NASH) with liver fibrosis.
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The regulator has granted priority review and set a Prescription Drug User Fee Act date of 14 March 2024.
Resmetirom is a once-daily, oral, thyroid hormone receptor (THR)-β selective agonist that targets crucial underlying causes of NASH in the liver.
Its clinical development programme consists of 18 clinical studies: 12 trials in Phase I, two in Phase II and four in Phase III.
The company is seeking approval to treat patients with NASH and liver fibrosis under the FDA’s accelerated approval pathway.
Madrigal CEO Bill Sibold stated: “NASH with liver fibrosis represents a significant unmet need in healthcare today: the disease has a serious impact on patients and, without treatment, it can lead to increased risk of cirrhosis, liver failure, liver cancer and premature mortality.
“Resmetirom is a liver-directed therapy that has demonstrated the potential to treat the liver fibrosis that is associated with these negative outcomes, while resolving the underlying steatohepatitis that drives the disease.”
NASH, which is a major cause of mortality related to the liver, is an advanced form of nonalcoholic fatty liver disease.
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