The European Committee for Medicinal Products for Human Use granted a positive opinion for Gilead Science’s Marketing Authorization Application for Epclusa for the treatment of all chronic hepatitis C genotypes, according to a press release from the manufacturer.
Epclusa (sofosbuvir/velpatasvir, Gilead Sciences) is an investigational, pangenotypic, once-daily tablet containing 400 mg of sofosbuvir and 100 mg of velpatasvir. The CHMP’s positive opinion was adopted following an accelerated review procedure and will now be reviewed by the European Commission, which has the authority to approve the drug for the European Union.
The drug was looked upon favorably by the committee based on data from multiple phase 3 studies — ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4.
In the ASTRAL-1, -2 and -3 studies, researchers treated 1,035 patients with HCV with or without compensated cirrhosis with sofosbuvir/velpatasvir for 12 weeks and 98% achieved sustained virologic response 12 weeks post-treatment. In the ASTRAL-4 study, researchers randomly assigned 267 patients with HCV and decompensated cirrhosis 12 weeks of sofosbuvir/velpatasvir with or without ribavirin or 24 weeks of sofosbuvir/velpatasvir with ribavirin for 12 weeks. In those who also received ribavirin, 94% achieved SVR12. This rate was higher compared with those who received sofosbuvir/velpatasvir alone for 12 weeks (83%) or 24 weeks (86%). The most common adverse events in the ASTRAL studies were headache, fatigue and nausea. These were comparable in incidence to the placebo group included in ASTRAL-1, according to the release.
The FDA granted priority review designation for sofosbuvir/velpatasvir in January.