Madrigal Pharmaceuticals' Resmetirom Receives FDA Breakthrough Therapy Designation for NASH Treatment with Liver Fibrosis

Madrigal Pharmaceuticals, Inc. has received U.S. Food and Drug Administration (FDA’s) Breakthrough therapy designation for resmetirom in the treatment of NASH patients with liver fibrosis. The company also announced the completion of the enrollment process for the outcomes portion of the MAESTRO-NASH biopsy trial, a Phase 3 clinical trial.

Publish Date: 18-04-2023 Source: Madrigal Pharmaceuticals, Inc.

Non-alcoholic steatohepatitis (NASH) is a severe form of non-alcoholic fatty liver disease (NAFLD) where the liver becomes inflamed due to fat accumulation. NASH can progress to include scarring (fibrosis/cirrhosis), preventing the liver from functioning properly. Since the disease has few or no symptoms, it can go unnoticed for decades. As fibrosis worsens, cirrhosis develops, and the liver becomes permanently damaged and can no longer work properly. Patients generally feel well in the early stages and only begin to have symptoms such as fatigue, weight loss, and weakness—once the disease is more advanced or cirrhosis develops. NASH is usually first suspected after elevations of liver enzymes in routine blood tests are found. A liver biopsy is needed to distinguish NASH from simple fatty liver.

NAFLD is highly prevalent in all continents, but the highest rates are reported from South America (31%) and the Middle East (32%), followed by Asia (27%), the USA (24%), and Europe (23%), whereas NAFLD is less common in Africa (14%).
NASH is now considered the second most common indication for liver transplantation in the USA after chronic hepatitis C and is still growing. The prevalence of NAFLD in the USA diagnosed by ultrasonography was estimated to be 24.13%. On the other hand, the prevalence of NAFLD was reported to be ~21.09%.

However, the current Non-Alcoholic Steatohepatitis (NASH) treatment market share, market uptake, and attribute analysis concerning the most potential emerging therapies (IVA337, Resmetirom, etc..) has been provided under the market outlook section of the study covering 8 MM countries; The United States, EU5 (Germany, Spain, France, Italy, UK) Japan and China.

In terms of pharmacologic therapies, several pharmaceutical products are being approved and under different phases of development for the Non-Alcoholic Steatohepatitis treatment. The key companies in the advanced development stage are Inventiva Pharma, Madrigal Pharmaceuticals, Inc, etc..

Based on solid domain and business knowledge, Thelansis Knowledge Partners has published the market outlook forecast report on Non-Alcoholic Steatohepatitis (NASH) to provide a clear understanding of disease area background, epidemiology, current and future competitions, the country-specific standard of care, and the complete market forecast for 2020 to 2030.

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