In this photo illustration, the Madrigal Pharmaceuticals logo is displayed on a smartphone screen.
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The U.S. Food and Drug Administration Thursday officially recognized First-ever treatment for common and potentially fatal disease a form of liver disease This affects millions of people around the world.
The FDA’s decision means Madrigal Pharmaceuticals Success has been achieved in disease areas where some big companies have failed or are still trying to enter. Madrigal’s shares rose more than 20% in extended trading on Thursday following the approval.
Novo Nordisk and Eli Lilly and Company The respective blockbuster weight-loss injections are being tested as treatments for the same liver disease called non-alcoholic steatohepatitis, or NASH.
Madrigal’s drug, which will be marketed as Rezdiffra, is designed to treat NASH patients with moderate to severe liver scarring. The treatment must be combined with diet and exercise, the FDA said.
NASH is a serious liver disease characterized by excess fat accumulation and inflammation in the liver, which can lead to liver scarring (also called fibrosis), as well as liver failure and liver cancer. This condition is often associated with other health problems, such as high blood pressure, type 2 diabetes, and obesity.
According to one study, approximately 6 million to 8 million people in the United States have NASH, which is associated with moderate to severe liver scarring. estimate FDA citation.
The drug will be available in April, Madrigal said in a statement. The company also said it has set up an assistance program to help those without Rezdiffra coverage. Madrigal did not say how much the treatment would cost.
“Previously, NASH patients with significant liver scarring had no drugs that could directly address liver damage,” said Dr. Nikolay Nikolov, acting director of the FDA’s Office of Immunology and Inflammation.
Madrigal’s drug specifically received “accelerated approval” from the FDA. The designation clears a drug more quickly if it addresses an unmet medical need for a serious disease and requires drugmakers to further study the treatment and verify its clinical benefit.
Madrigal’s drug helps reduce fat accumulation by activating thyroid hormone receptors in the liver. Patients take it orally every day.
in later stages study Rezdiffra, published last month, helps resolve NASH symptoms and improve liver scarring without making the condition worse. Of note, the rates of serious adverse events were comparable between the group of patients taking the drug and those receiving placebo.
The most common side effects associated with treatment are diarrhea, nausea, and vomiting.
Some experts have begun calling for NASH Metabolic dysfunction associated steatohepatitis (MASH) to avoid potentially abusive language.
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