FDA Approves First Drug for Common, Serious Liver Disease

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Millions of Americans whose livers develop scar tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.

tissue due to a common disease now have the first approved drug, Rezdiffra, to treat the condition, the U.S. Food and Drug Administration announced Thursday.scarring did not have a medication that could directly address their liver damage,” said Dr. Nikolay Nikolov, acting director of the Office of Immunology and Inflammation in the FDA's Center for Drug Evaluation and Research.

Rezdiffra is made by Madrigal Pharmaceuticals and was approved based on data collected after a year as part of an ongoing 54-month trial. That data assessed improvement in levels of liver scarring compared to patients who were taking a placebo.

 

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