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Pharmaceuticals / Submissions and Approvals

China FDA Approves Combination Treatment for Chronic Hepatitis C

May 4, 2017
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China FDA has approved Bristol-Myers Squibb’s direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).

Daklinza has been approved in China for combination use with other agents, including sofosbuvir, for adult patients with HCV genotypes 1-6 infection.  The approval was based on clinical results showing one percent of genotype 1b patients who had been previously interferon-ineligible or interferon-intolerant achieved sustained cure at post-treatment week 24.

Sofosbuvir is under review by the CFDA and is not currently licensed in China.

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