NEW DELHI: The US Food and Drug Administration (FDA) on Thursday approved the first medication for people with a severe type of non-alcoholic fatty liver disease. The medication, Rezdiffra by Madrigal Pharmaceuticals, was found to improve liver scarring in a clinical trial with hundreds of patients suffering from non-alcoholic steatohepatitis (NASH), the most severe form of the condition caused by fat buildup in the liver.
FDA’s Nikolay Nikolov said, “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage.” “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise,” he added.
NASH affects 6-8 million Americans and is linked to health issues like high blood pressure, type 2 diabetes, and obesity. Symptoms include weakness, fatigue, yellowing of the skin, spider-like blood vessels, and more. If NASH progresses to cirrhosis, it can lead to liver failure requiring a transplant.
Rezdiffra, or resmetirom, is an oral drug targeting the root causes of NASH. A trial with 966 participants showed that more Rezdiffra-treated subjects achieved resolution or improvement in liver scarring compared to the placebo group. Common side effects include diarrhea and nausea.
Madrigal CEO Bill Sibold highlighted the ‘accelerated approval’ after 15 years of research, while Lorraine Stiehl of the American Liver Foundation praised the treatment. “The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development,” he said.
The drug is expected to be accessible to US patients in April.
FDA’s Nikolay Nikolov said, “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage.” “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients, in addition to diet and exercise,” he added.
NASH affects 6-8 million Americans and is linked to health issues like high blood pressure, type 2 diabetes, and obesity. Symptoms include weakness, fatigue, yellowing of the skin, spider-like blood vessels, and more. If NASH progresses to cirrhosis, it can lead to liver failure requiring a transplant.
Rezdiffra, or resmetirom, is an oral drug targeting the root causes of NASH. A trial with 966 participants showed that more Rezdiffra-treated subjects achieved resolution or improvement in liver scarring compared to the placebo group. Common side effects include diarrhea and nausea.
Madrigal CEO Bill Sibold highlighted the ‘accelerated approval’ after 15 years of research, while Lorraine Stiehl of the American Liver Foundation praised the treatment. “The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development,” he said.
The drug is expected to be accessible to US patients in April.