In this illustrated photo, the Madrigal Pharmaceuticals logo is displayed on the smartphone screen.
Rafael Enrique | SOPA Images | Light Rocket | Getty Images
Food and Drug Administration Thursday approved First treatment for a common and potentially deadly disease Forms of liver disease It affects millions of people around the world.
The FDA decision means: madrigal pharmaceutical The company has succeeded in disease areas where several large companies have failed or are still trying to enter. Madrigal stock rose more than 20% in extended trading Thursday following the approval.
novo nordisk and Eli Lilly The companies are testing their innovative weight-loss injections as treatments for a similar liver disease called nonalcoholic steatohepatitis (NASH).
Madrigal’s drug, sold as Rezdifla, is specifically approved to treat NASH patients with moderate to advanced liver scarring. According to the FDA, this treatment requires a combination of diet and exercise.
NASH is a serious liver disease characterized by excessive fat accumulation and inflammation in the liver, which can lead to liver scarring, also known as fibrosis, along with 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 report, approximately 6 to 8 million people in the United States have NASH with moderate to progressive liver scarring. estimate Cited by FDA.
Madrigal said in a statement that the drug is expected to be released in April. The company also said it has launched an assistance program to help uninsured people access RezdiFla. Madrigal did not say how much the treatment would cost.
“Until now, NASH patients with significant liver scarring have not had a drug that directly addresses liver damage,” said Dr. Nikolai Nikolov, acting director of the FDA’s Office of Immunology and Inflammation.
Madrigal’s drug specifically received “early approval” from the FDA. This designation allows drugs to be approved more quickly if they meet an unmet medical need for serious conditions, and allows drug companies to further study treatments and verify their clinical benefits. is required.
Madrigal’s drug works by activating thyroid hormone receptors in the liver to reduce fat accumulation. Patients take it by mouth daily.
In the latter half study Rezdiffra, introduced last month, has helped reduce NASH symptoms and improve liver scarring without worsening the condition. Of note, the incidence of serious adverse events was similar between the group of patients who received the drug and another group who received a placebo.
The most common treatment-related side effects were diarrhea, nausea, and vomiting.
Some experts are starting to call NASH metabolic dysfunction-associated steatohepatitis, or MASH; To avoid words that may be prejudiced.
