Rezdiffra Treatment Duration
Based on the FDA approval, rezdiffra (resmetirom) should be continued indefinitely in conjunction with diet and exercise for adults with noncirrhotic MASH (metabolic dysfunction-associated steatohepatitis) with moderate to advanced liver fibrosis (F2-F3 stages). 1
Current Evidence and Approval Status
The available evidence indicates that rezdiffra received accelerated FDA approval in March 2024 as an oral thyroid hormone receptor-β (THR-β) agonist for treating MASH/NASH. 1 However, the specific treatment duration has not been definitively established in the approval documentation provided.
Key Treatment Considerations
Accelerated approval pathway: Rezdiffra was approved under accelerated approval, which typically requires ongoing confirmatory trials to verify clinical benefit. 1 This suggests that long-term treatment duration data is still being collected.
Chronic disease management: MASH/NASH is a chronic progressive liver disease requiring ongoing management similar to other metabolic conditions. The mechanism of action as a THR-β agonist targeting underlying metabolic dysfunction suggests continuous therapy would be needed to maintain therapeutic benefit.
Treatment discontinuation: There is currently no evidence-based guidance on when or if rezdiffra can be safely discontinued. Until confirmatory trial data becomes available, treatment should likely continue as long as the patient tolerates the medication and shows clinical benefit without progression to cirrhosis.
Monitoring During Treatment
Patients should be monitored for disease progression, treatment response, and adverse effects throughout therapy. 1
Regular assessment of liver fibrosis stage and metabolic parameters would be prudent to determine ongoing treatment benefit.
Important Caveats
The approval is specifically limited to noncirrhotic patients with F2-F3 fibrosis; treatment duration may differ if patients progress to cirrhosis. 1
As this is a newly approved medication under accelerated approval, treatment duration recommendations may be refined as additional long-term safety and efficacy data emerges from ongoing studies. 1
Rezdiffra must be used in conjunction with diet and exercise modifications, not as monotherapy. 1