ET 07:31

AbbVie (ABBV) Secures EU Approval for MAVIRET in Pediatric Hepatitis C

IMP5.5
SNT+0.6
CONF95%
Regulatory

AbbVie (ABBV) announced on June 23, 2026, that it received European Commission approval for its MAVIRET (glecaprevir/pibrentasvir) drug. This expands its indication to treat chronic hepatitis C (HCV) in children and adolescents aged 3-12 years across the European Union, broadening the drug's market reach. MAVIRET is a pan-genotypic, once-daily, ribavirin-free regimen already approved for adults and adolescents aged 12 and older. This new approval specifically targets genotype 1-6 chronic HCV infection in the younger pediatric population. The approval was based on data from the DORA Part 2 and Part 1 studies. DORA Part 2 showed 98% (46 of 47) of patients achieved a sustained virologic response 12 weeks post-treatment (SVR12). In DORA Part 1, 80% (12 of 15) of patients aged 6-12 also achieved SVR12.

EditorWong Mei Ling