VoseviHepatitis C infection in children aged 12 years and older - plus new 200/50/50mg strength tablet
Licence extension / variation and new formulation
Development and Regulatory status
Recommended for approval (Positive opinion)
Jul 21EU CHMP issues a positive opinion recommending an extension to the indication for Vosevi to include use in children aged 12 and older. The proposed new indication is treatment of chronic hepatitis C virus (HCV) infection in patients aged 12 years and older and weighing at least 30kg. The CHMP also recommended the addition of a new 200/50/50 mg strength for the film-coated tablets .
Fixed dose combination of a pan-genotypic inhibitor of the HCV NS5B RNA-dependent RNA polymerase (sofosbuvir), pan-genotypic HCV inhibitor (velpatasvir) and a pan-genotypic inhibitor of the HCV NS3/4A protease (voxilaprevir)
Prevalence of HCV infection in children and adolescents has been reported to vary from 0.05% to 0.36% in the US and Europe .
Hepatitis C infection in children aged 12 years and older - plus new 200/50/50mg strength tablet