← All approvals · Kidney, liver & lung · 2024
Rezdiffra (resmetirom)
The FDA approved Rezdiffra (resmetirom) on March 14, 2024 to treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring.
- Brand name
- Rezdiffra
- Generic name
- resmetirom
- FDA approval date
- March 14, 2024
- Approved use (FDA wording)
- To treat noncirrhotic non-alcoholic steatohepatitis with moderate to advanced liver scarring
- Company
- Madrigal
- Application
- NDA217785
- Dosage form / route
- TABLET · ORAL
- Drug class (EPC)
- Thyroid Hormone Receptor beta Agonist [EPC]
- Boxed warning on label
- Not listed
- Category on this site
- Kidney, liver & lung
Indications and usage, from the FDA label
REZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as 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 MASH and fibrosis [see Clinical Studies (14) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Limitations of Use Avoid use of REZDIFFRA in patients with decompensated cirrhosis [see Use in Specific Populations (8.7) , Clinica…