Rezdiffra FDA Approval History
Last updated by Judith Stewart, BPharm on March 19, 2024.
FDA Approved: Yes (First approved March 14, 2024)
Brand name: Rezdiffra
Generic name: resmetirom
Dosage form: Tablets
Company: Madrigal Pharmaceuticals, Inc.
Treatment for: Nonalcoholic Steatohepatitis
Rezdiffra (resmetirom) is a thyroid hormone receptor-beta (THR-beta) agonist indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
- This indication is approved under accelerated approval based on improvement of NASH and fibrosis. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
- NASH is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NAFLD is a condition in which fat builds up in the liver, and NASH occurs when the fat buildup in the liver leads to hepatitis and cirrhosis, which may cause liver cancer.
- Rezdiffra works in the treatment of NASH by acting as an agonist of THR–β in the liver. THR-β action is key to proper liver function, including regulation of mitochondrial activity such as breakdown of liver fat and control of the level of normal, healthy mitochondria. People with NASH have reduced levels of THR-β receptor activity in the liver.
- Rezdiffra tablets are administered orally once daily.
- Warnings and precautions associated with Rezdiffra include hepatotoxicity and gallbladder-related adverse reactions.
- Common adverse reactions include diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.
Development timeline for Rezdiffra
Further information
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