The US Food and Drug Administration (FDA) approved the first-ever medication targeting a severe variant of non-alcoholic fatty liver disease (NAFLD) on Thursday.
Madrigal Pharmaceuticals’ Rezdiffra had clinched regulatory approval following compelling evidence of its efficacy in combating liver scarring among patients suffering from non-alcoholic steatohepatitis (NASH), the most severe form of NAFLD.
NASH has affected millions across the United States and is often associated with a spectrum of other health complications, such as high blood pressure, type 2 diabetes, and obesity. Symptoms could range from fatigue to jaundice, signaling significant health risks. If left untreated, NASH could progress to cirrhosis, posing a serious threat of liver failure and the need for transplantation.
Until then, treatment options for patients with NASH and substantial liver scarring had been limited, primarily focusing on lifestyle modifications such as dietary changes and exercise. However, the FDA’s green light for Rezdiffra marked a pivotal advancement in managing this challenging condition.
Nikolay Nikolov, representing the FDA, emphasized the importance of this milestone approval, stating, “Today’s approval of Rezdiffra will, for the first time, provide a treatment option for these patients.”
Rezdiffra, also known as resmetirom, is an oral medication designed to address the underlying causes of NASH. Clinical trials involving nearly a thousand participants had demonstrated promising outcomes, with a greater proportion of Rezdiffra-treated patients experiencing resolution or improvement in liver scarring compared to those receiving a placebo. While some side effects, such as diarrhea and nausea, had been reported, they had been generally manageable.
Bill Sibold, CEO of Madrigal Pharmaceuticals, had expressed gratitude for the FDA’s approval, acknowledging the extensive research and development efforts that had contributed to this milestone. Further, the American Liver Foundation’s Lorraine Stiehl applauded the FDA’s decision, underscoring the positive impact that Rezdiffra could have on the lives of NASH patients.
Madrigal had announced plans to make Rezdiffra available to patients in the United States starting in April, offering hope to those grappling with the challenges of severe non-alcoholic fatty liver disease.
Other POP! stories that you might like:
Longest surviving iron lung patient Paul Alexander dies, leaves inspiring legacy
Unsung heroes of botched ‘Willy Wonka Experience’ arise despite being put in a bad light
Reddit is allowing reward users to buy on their IPO, looks like everyone is interested
Olivia Rodrigo giving out emergency contraceptive pills at her concert has the internet divided
