Chinese regulator clears Gilead's newest hepatitis C drug

The China State Drug Administration (CSDA) has approved Epclusa (sofosbuvir 400mg/velpatasvir 100mg) for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection, from US biotech major Gilead Sciences (Nasdaq: GILD).

The CSDA, which replaced the China Food and Drug Administration (CFDA) in March this year, also approved Epclusa in combination with ribavirin (RBV) for adults with HCV and decompensated cirrhosis. Epclusa is the first pan-genotypic HCV single tablet regimen (STR) approved in China.

The combination of sofosbuvir and velpatasvir is currently the subject of a patent challenge in China by the Geneva, Switzerland-based aid group Médecins Sans Frontières (MSF). “If granted, the unjustified patent on the combination of these two medicines would give Gilead the monopoly over production and sales of the treatment in China,” MSF claims.