Canada grants updated labeling of Epclusa

US biotech major Gilead Sciences today announced the approval in Canada for expanded indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C in patients co-infected with HIV.

Gilead Sciences Canada received from Health Canada a Notice of Compliance or NOC for updated labeling of Epclusa, the first all-oral, pan-genotypic, once-daily single tablet regimen or STR for the treatment of adults with chronic hepatitis C virus (HCV) infection, to include use in patients co-infected with HIV-1.

The supplemental new drug submission was supported by data from the open-label, Phase III ASTRAL-5 study, which evaluated 12 weeks of treatment with Epclusa in 106 subjects.