Revolutionary Treatment for Fatty Liver Disease: First Drug to Combat Metabolic Dysfunction and Advanced Fibrosis

Breaking Ground in Liver Disease: Understanding the First Treatment for Fatty Liver

Arun Sanyal, MD, Director of the VCU Stravitz-Sanyal Liver Institute for Liver Disease and Metabolic Health, shares insights on the groundbreaking approval of resmetirom Rezdiffra, the first drug to treat fatty liver disease, affecting up to 15 million Americans.

Fatty liver disease causes fat accumulation in the liver, often without immediate symptoms. However, when inflammation and damage occur due to this excess fat buildup, it's termed metabolic dysfunction-associated steatohepatitis MASH. This condition is the leading cause of liver-related illnesses and deaths.

The approval signifies a major milestone for patients dealing with MASH and significant liver scarring, as it now offers an effective therapeutic option. Our patients with advanced liver damage due to MASH will have access to Rezdiffra, says Dr. Sanyal. This approval is of collaborative efforts between the scientific community and patients.

Rezdiffra will be avlable for patients starting in April 2024, potentially transforming liver health outcomes.

Key Points on Rezdiffra:

• Condition Treated: The new drug targets metabolic dysfunction-associated steatohepatitis MASH, which is characterized by fat accumulation and inflammation within the liver. As MASH progresses, it can lead to scarring fibrosis and ultimately cirrhosis, cancer, or necessitate a liver transplant.

• Target Audience: Approximately 6 to 8 million Americans are estimated to suffer from MASH, often accompanied by conditions like high blood pressure, type 2 diabetes, obesity, and elevated blood fats. Rezdiffra is designed for those with moderate to advanced fibrosison the brink of cirrhosis.

• Mechanism of Action: Beyond lifestyle changes such as diet and exercise, which are currently recommed for MASH management, Rezdiffra acts directly on a liver protein to reduce fat accumulation, inflammation, and scarring. Clinical trials show it can halt or even reverse fibrosis progression.

Safety Considerations:

Before starting treatment with Rezdiffra, patients should consult their healthcare provider about its suitability in their specific situation. Biopsies are not typically needed for diagnosis as noninvasive tests identify MASH when a patient has stage 2 or 3 fibrosis.

Rezdiffra is taken orally and can cause common side effects such as diarrhea and nausea. Importantly, patients with severe cirrhosis should avoid the drug. Those using Rezdiffra who experience worsening liver function symptoms must discontinue treatment immediately and consult their healthcare provider.

Significance of Approval:

This approval marks a pivotal moment in liver disease management, considering that liver disease is among the leading causes of death in the U.S., ranking 9th, with an increasing burden globally. Patients suffering from MASH, especially those dealing with conditions like obesity or type 2 diabetes, are at heightened risk for adverse cardiovascular events and health complications.

The FDA's decision to approve Rezdiffra through its accelerated approval pathway highlights its potential as a significant advance in addressing unmet medical needs in serious diseases. Madrigal Pharmaceuticals must now conduct post-approval studies to confirm the clinical benefit of Rezdiffra, which was detled in a recent article published in The New England Journal of Medicine.

For More Information:

• Explore the VCU Stravitz-Sanyal Liver Institute for insights into innovative research tackling metabolic health challenges.

• Dive into updates on advancements at VCU and VCU Health.

Contact Information:

• Phone: 1-800-762-6161

• Copyright ? 2024 VCU Health. All rights reserved.

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