The U.S. Food and Drug Administration (FDA) has recently given its approval for a groundbreaking new medication called Rezdiffra (resmetirom) for the treatment of noncirrhotic non-alcoholic steatohepatitis (NASH) in adults with moderate to advanced liver scarring. This marks a significant milestone as it is the first medication available that directly targets liver damage in patients with NASH.
NASH is a condition that arises from the progression of nonalcoholic fatty liver disease and can result in liver inflammation, scarring, and dysfunction. It is often associated with other health issues such as high blood pressure and type 2 diabetes. Studies estimate that approximately 6-8 million people in the U.S. have NASH with moderate to advanced liver scarring, a number that is expected to rise in the coming years.
Rezdiffra works as a partial activator of a thyroid hormone receptor, helping to reduce the buildup of fat in the liver. Clinical trials evaluating the safety and efficacy of Rezdiffra showed promising results, with a higher percentage of patients experiencing resolution of NASH or improvement in liver scarring compared to those on a placebo. However, common side effects include diarrhea and nausea, and caution should be taken with patients who have decompensated cirrhosis or those taking certain medications like statins, which can interact with Rezdiffra.
The accelerated approval of Rezdiffra was granted to Madrigal Pharmaceuticals, who also received Breakthrough Therapy, Fast Track, and Priority Review designations for this indication. This approval underscores the FDA’s commitment to ensuring the safety and effectiveness of drugs for human use, while also regulating food, cosmetics, and tobacco products to protect public health. Patients with NASH and liver scarring now have an innovative treatment option available to address their condition and improve their quality of life.
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