This will help many people.
The U.S. Food and Drug Administration announced on Thursday the approval of Rezdiffra, the first drug approved for treating non-cirrhotic non-alcoholic steatohepatitis (NASH), a common condition characterized by scar tissue formation in the liver. NASH with liver scarring affects an estimated 8 million Americans and is often associated with conditions like high blood pressure and type 2 diabetes.
Dr. Nikolay Nikolov, acting director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, highlighted the significance of Rezdiffra’s approval in addressing liver damage in patients with NASH and notable liver scarring. He emphasized that Rezdiffra provides a treatment option alongside lifestyle modifications like diet and exercise.
NASH develops due to inflammation caused by factors such as obesity, diabetes, and high blood pressure, leading to fat accumulation, liver scarring, and dysfunction. Rezdiffra, a partial activator of a thyroid hormone receptor, targets liver fat accumulation by reducing inflammation.
The drug received accelerated approval from the FDA due to addressing an unmet medical need. Approval was based on data collected from an ongoing 54-month trial, where patients taking Rezdiffra showed improvement in liver scarring levels compared to those on a placebo.
Results showed that 24% to 36% of NASH patients taking 100 milligrams of Rezdiffra saw their NASH resolve without worsening of liver scarring, compared to 9% to 13% of those on placebo. Similar ratios experienced stabilization of NASH without worsening liver scarring.
The FDA noted the significance of these results within one year, considering NASH typically progresses slowly over years or decades. However, Rezdiffra may cause side effects like diarrhea and nausea, and warnings about drug-induced liver toxicity and gallbladder issues are included in its label.
Patients with advanced liver disease or those taking cholesterol-lowering statins should consult their doctors before using Rezdiffra, according to the FDA. Despite potential side effects, the approval of Rezdiffra marks a significant advancement in the treatment of NASH-related liver scarring and offers hope for millions of affected individuals.
Discussion about this post