American Liver Foundation Statement on FDA Approval of Resmetirom

2024-03-14

上市批准加速审批

First drug therapy treatment for nonalcoholic steatohepatitis (NASH) provides hopes to millions of Americans

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

"American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl, Chief Executive Officer, American Liver Foundation. "Until now, there were no approved treatments for NASH and today's decision by the FDA provides hope to millions of Americans dealing with this dangerous and progressive disease."

First drug therapy treatment for nonalcoholic steatohepatitis (NASH) provides hopes to millions of Americans.

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In the United States, NAFLD affects approximately 80-100 million people, among whom nearly 25% progress to NASH. Many do not know they have the disease. 11% of NASH patients will develop cirrhosis or liver failure. NASH may progress to hepatocellular carcinoma (HCC). NASH is expected to become the leading cause of liver transplantation in the United States by 2025.

"Innovation is the key for treating all types of liver diseases, especially one of this magnitude," said Emmanuel Thomas, MD, PhD, Board Chair of ALF. "We applaud the innovation shown by Madrigal Pharmaceuticals in developing the first-ever FDA-approved treatment for NASH in patients with fibrosis. While the target patient population for this drug will initially be limited, it is our hope that it will eventually be made available and affordable to all those affected by NASH."

American Liver Foundation offers many free resources to patients and families affected by liver disease. In addition to our toll-free helpline, 1-800-GO-LIVER, and live chat available at liverfoundation.org, patients with NASH are also encouraged to join ALF's free Facebook support group, Life with NAFLD/NASH, or a new support network for liver patients, "Sharing the Journey—an ALF support network for patients." Caregivers are encouraged to join our new support network, "Sharing the Journey—an ALF support network for caregivers." To find out if you are at risk for nonalcoholic fatty liver disease take a quick quiz available in English at: thinkliverthinklife.org/quiz and in Spanish at: thinkliverthinklife.org/prueba.

*Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively. Learn more about the terminology changes and how it affects patients by watching this video.

About the American Liver Foundation

American Liver Foundation (ALF) is a national community of patients, caregivers and medical professionals dedicated to helping people improve their liver health. Providing guidance and life-saving resources, we are a beacon for the 100 million Americans affected by liver disease. We advocate for patients and families, fund medical research and educate the public about liver wellness and disease prevention. We bring people together through our educational programs and events and create a network of support that lasts a lifetime. ALF is the largest organization focused on all liver diseases and the trusted voice for patients and families living with liver disease. For more information visit www.liverfoundation.org or call 1-800-GO-LIVER.

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SOURCE American Liver Foundation

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