FDAsafety guidance72% confidence
Hepatitis C Medicines (Mavyret, Zepatier, and Vosevi): Drug Safety Communication - Due to Rare Occurrence of Serious Liver Injury in Some patients with Advanced Liver Disease
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ophthalmology) as Viridian Therapeutics.
Regulatory Analysis
FDA has received reports that the use of Mavyret, Zepatier, or Vosevi to treat chronic Hepatitis C in patients with moderate to severe liver impairment has resulted in rare cases of worsening liver function or liver failure.
Supporting Context
- Therapeutic area
- Ophthalmology · Thyroid Eye Disease
- Sub-indication
- Ophthalmology
Related signal: Viridian Therapeutics initiates trial for VRDN-003 in Thyroid Eye Disease