AbbVie : EU Approves Change To Marketing Authorization For Maviret

(RTTNews) - AbbVie (ABBV) said Friday that the European Commission has approved a change to the marketing authorization for Maviret to shorten once-daily treatment duration from 12 to 8 weeks in treatment-naïve, compensated cirrhotic, chronic hepatitis C (HCV) patients with genotype (GT) 3 infection.

Maviret was already indicated as an 8-week, pan-genotypic (GT1-6), once-daily regimen for treatment-naïve HCV patients without cirrhosis, and as an 8-week, once-daily regimen for treatment-naïve GT 1, 2, 4, 5 and 6 HCV patients with compensated cirrhosis.

"A shorter treatment duration means that more patients with HCV can be treated with an 8-week course of MAVIRET in the absence of initial tests to determine their genotype or degree of fibrosis or cirrhosis," said Janet Hammond, vice president, general medicine and virology therapeutic area, AbbVie.

Maviret is approved in the European Union for the treatment of chronic hepatitis C virus (HCV) infection in adults and adolescents aged 12 to <18 years across all major genotypes (GT1-6).