US approves first medication for severe non-alcoholic fatty liver disease

Mar15,2024



New Delhi: The US Food and Drug Administration (FDA) on Thursday approved the first drug for people with severe form of non-alcoholism. fatty liver disease, Madrigal Pharmaceuticals' drug, Rezdifra, was found to improve liver lesions in a clinical trial of hundreds of patients with the disease. Non-Alcoholic Steatohepatitis ,nash), the most serious form of the condition caused by a buildup of fat in the liver.
“Previously, patients with NASH who had significant liver damage did not have any drugs that could directly treat their liver damage,” said the FDA's Nikolay Nikolov. “Today's approval of Razdifra will, for the first time, provide a treatment option in addition to diet and exercise for these patients,” he said.
NASH affects 6-8 million Americans and is linked to health problems such as high blood pressure, type 2 diabetes, and obesity. Symptoms include weakness, fatigue, yellowing of the skin, spider-like blood vessels and more. If NASH turns into cirrhosis, it can lead to liver failure that may require a transplant.
Razedifra, or resmetirom, is an oral medication targeting the root causes of NASH. A trial with 966 participants showed that more Rezdifra-treated subjects achieved resolution or improvement in liver lesions than the placebo group. Common side effects include diarrhea and nausea.
Madrigal CEO Bill Siebold highlights 'accelerated approval' after 15 years of research, while Loren Stiehl American Liver Foundation Appreciated the treatment. “The accelerated approval of Razdifra is the result of more than 15 years of research by our founder, Dr. Becky Taub, and a small R&D team that tackled one of the greatest challenges in drug development,” he said.
The drug is expected to be available to US patients in April.



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