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HomeLatest Pharma-NewsFirst investigational drug therapy for liver disease non alcoholic steatohepatitis (NASH) awaiting...

First investigational drug therapy for liver disease non alcoholic steatohepatitis (NASH) awaiting FDA approval

Dec. 05, 2019: A large Phase III clinical trial designed in collaboration with Virginia Commonwealth University is the first to demonstrate the safety and effectiveness of an oral medication to patients with nonalcoholic steatohepatitis (NASH), a chronic liver disease and a leading cause for liver transplantation in the U.S.(currently lack an approved drug therapy, but this may soon change).

As per the Results from the interim analysis of the REGENERATE study, sponsored by the Intercept Pharmaceuticals, will publish in the medical journal The Lancet this week.

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Approximately 7 million and 30 million U.S. adults suffer from this desease, a severe form of fatty liver disease (unrelated to alcohol abuse) but closely related to obesity and Type 2 diabetes.

Patients suffering from NASH, fat deposited in the liver damages causes inflammation. NASH can progress in order to  include scarring, called fibrosis, which prevents the liver from functioning properly which can lead to liver cancer, liver failure or death. https://www.eurekalert.org/pub_releases/2019-12/vcu-fid120519.php

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