Gilead's Epclusa now cleared for marketing in Europe

The European Commission has granted marketing authorization for US biotech giant Gilead Sciences’ (Nasdaq: GILD) Epclusa (sofosbuvir 400/velpatasvir), the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection.

Gilead’s shares edged up 1.5% to $86.75 in mid-morning US trading.

The combination of sofosbuvir and velpatasvir (SOF/VEL) for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). SOF/VEL is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis.