"FDA Greenlights First-Ever Drug for Fatty Liver Disease NASH"
The FDA has approved Rezdiffra (resmetirom) as the first treatment for adults with noncirrhotic non-alcoholic steatohepatitis (NASH) and moderate to advanced liver scarring, to be used alongside diet and exercise. NASH, a result of nonalcoholic fatty liver disease, can lead to liver scarring and dysfunction. Rezdiffra, a partial activator of a thyroid hormone receptor, showed promising results in reducing liver fat accumulation in a 54-month trial. Common side effects include diarrhea and nausea, and precautions include drug-induced liver toxicity and gallbladder-related side effects. The approval was granted under the accelerated approval pathway, and a postapproval study is ongoing to assess clinical benefit after 54 months of treatment.
- FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease FDA.gov
- US FDA approves first drug for fatty liver disease NASH Reuters
- Madrigal Stock Slumps Ahead Of Potential Approval For First-Ever MASH Treatment Investor's Business Daily
- FDA approves first MASH drug: Madrigal's Rezdiffra breaks ground in notorious biopharma graveyard FiercePharma
- Madrigal Pharmaceuticals gets first FDA approval for drug for liver disease MASH MarketWatch
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