China's FDA approves Sovaldi

25 September 2017

The China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection, from US biotech major Gilead Sciences (Nasdaq: GILD).

Sovaldi was approved for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen. Sovaldi is the first Gilead HCV medicine approved in China.

Gilead is not the first to get Chinese approval for a hepatitis C treatment, It was beaten to the market by Bristol-Myers Squibb (NYSE: BMY), whose combination of Daklinza (daclatasvir) with Sunvepra (asunaprevir)approved for patients with genotype 1b of the disease, while Daklinza in combination with Gilead’s Sovaldi was approved across genotypes 1–6, in April this year.

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