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FDA Approves First Treatment for Liver Scarring Due to Fatty Liver Disease




New Drug Approved by FDA for Treatment of Serious Liver Disease

New Drug Approved by FDA for Treatment of Serious Liver Disease

FDA Approves Rezdiffra to Address Liver Scarring

The U.S. Food and Drug Administration (FDA) announced on Thursday the approval of a groundbreaking drug, Rezdiffra (resmetirom), for the treatment of nonalcoholic steatohepatitis (NASH), a common form of liver inflammation. This approval marks a significant milestone in the medical field.

NASH: A Major Concern with Serious Consequences

NASH, also known as metabolic dysfunction-associated steatohepatitis (MASH), can lead to severe liver scarring and dysfunction. The primary cause of NASH is the accumulation of excess fatty cells in the liver, which results in inflammation and various complications. Individuals with NASH often experience comorbidities like type 2 diabetes and high blood pressure.

Hope for Patients with Notable Liver Scarring

Patients diagnosed with NASH and significant liver scarring previously had limited treatment options. However, Rezdiffra, a partial activator of the thyroid hormone receptor, offers a breakthrough in addressing liver damage. With Rezdiffra, patients can now have a treatment option to complement their dietary and exercise regimen.

In clinical trials, Rezdiffra demonstrated a substantial reduction in liver fat accumulation, positively impacting patients with NASH and advancing liver scarring. It opens doors for over 6-8 million patients in the U.S., who suffer from moderate to advanced liver scarring due to NASH.

Main Considerations and Precautions

While the FDA’s approval of Rezdiffra brings hope, patients need to exercise caution and be aware of potential side effects and necessary precautions:

  • Common side effects of Rezdiffra include diarrhea and nausea.
  • Warnings for the drug involve the risk of drug-induced liver toxicity and gallbladder-related side effects.
  • Patients with decompensated cirrhosis should not use Rezdiffra.
  • Patients must discontinue the treatment and seek medical attention if signs of worsening liver function develop.
  • Patients should be cautious when using Rezdiffra in combination with other drugs, such as statins for lowering cholesterol, due to potential interactions.

Impact and Future Possibilities

This landmark approval of Rezdiffra exemplifies the FDA’s commitment to addressing unmet medical needs. It holds the potential not only for improving the lives of millions with NASH-related liver scarring but also for advancing further research and development in the field.

As one of the largest steps forward in the treatment of liver diseases, the approval of Rezdiffra provides hope to patients and medical professionals alike.

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