Friday, July 19, 2024

Resmetirom A New Drug For NASH Patients Approved By FDA


Have the scientists finally discovered a new drug for NASH patients? The Food and Drug Administration (FDA) has announced a breakthrough in the treatment of nonalcoholic steatohepatitis (NASH), a common form of liver inflammation. On Thursday, the agency approved Resmetirom, the first medication specifically designed to target NASH.

Growing Public Health Concern of NASH

NASH, also known as metabolic dysfunction-associated steatohepatitis (MASH), occurs when excess fat accumulates in the liver, leading to inflammation and scarring. Unlike alcoholic fatty liver disease, NASH is not caused by excessive alcohol consumption. This condition is often a consequence of obesity, type 2 diabetes, or other metabolic disorders like high blood pressure. The FDA estimates that 6 to 8 million Americans suffer from NASH with moderate to advanced liver fibrosis (scarring). Left untreated, NASH can develop into more severe complications like cirrhosis, liver failure, and even cancer.

Resmetirom: New Drug for NASH Patients

Until now, there haven’t been any approved medications for treating NASH. Doctors primarily relied on lifestyle modifications to manage the condition. These interventions focused on weight loss through dietary adjustments, blood sugar control, and regular exercise.

Developed by Madrigal Pharmaceuticals, Resmetirom represents excellent hope for NASH treatment. The medication, marketed under Rezdiffra, received the “Breakthrough Therapy” designation from the FDA in April. This designation is reserved for promising drugs intended to treat severe conditions and demonstrate significant improvement over existing therapies.

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How Does Resmetirom Work?

Resmetirom works by activating a specific thyroid hormone receptor within the liver. This activation helps to reduce fat accumulation, thereby reducing the underlying cause of NASH. The medication is administered orally daily and is specifically approved for patients with moderate to advanced liver fibrosis associated with NASH. However, it is essential to note that Resmetirom is intended to be used with a healthy diet and exercise program for optimal results.

What are the Clinical Trial Results of Resmetirom?

Clinical trial data published in February 2024 gives a promising report for Resmetirom’s efficacy. The study revealed that over 25% of participants taking the 80-milligram Resmetirom dose achieved NASH resolution without worsening fibrosis. Similarly, nearly 30% of those receiving the 100-milligram dose experienced the same outcome. In stark contrast, less than 10% of the placebo group achieved NASH resolution. The study also showed that Resmetirom helped lower LDL (“bad”) cholesterol levels and improved liver enzyme function.

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Unanswered Questions About New Research

While the approval of Resmetirom marks a significant milestone, some questions remain unanswered. The optimal duration of treatment with Resmetirom is yet to be determined, and further research is needed to establish this aspect. Researchers are also actively investigating the long-term safety and efficacy of Resmetirom.

The FDA’s approval of this new drug for NASH, Resmetirom, offers some hope for millions of people struggling with NASH. This new medication provides a much-needed therapeutic option for managing this progressive liver disease. With continued research, Resmetirom has the potential to significantly improve the lives of NASH patients and reduce the burden of this growing public health concern.

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