Rezdiffra (resmetirom)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- resmetirom
- Company
- Madrigal Pharmaceuticals EU Limited
- Status
- Authorised
- Therapeutic area
- Non-alcoholic Fatty Liver Disease; Liver Cirrhosis
- CHMP opinion
- Thu 19 Jun 2025
- EU approval
- Mon 18 Aug 2025
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/006220
- ATC
- A05
- Official record
- www.ema.europa.eu
Indication
Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (fibrosis stages F2 to F3).
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.