Gilead Sciences has gotten the approval from the China Drug Administration (CDA) of Epclusa for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection, the company said Wednesda.
The CDA 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 safety and efficacy profile of Epclusa are supported by large clinical and real-world global datasets,” said Professor Lai Wei, Peking University People’s Hospital and Institute of Hepatology, Peking University. “With high cure rates across all HCV genotypes, Epclusa could increase HCV treatment in China by potentially eliminating the need for genotype testing, which can be a barrier to treatment in many settings.”
HCV is the fourth-most commonly reported infectious disease in China, with approximately 10 million people infected. HCV genotypes 1, 2, 3 and 6 account for more than 96 percent of all cases, the company said.
“As the first once-daily, interferon-free single tablet regimen for HCV patients regardless of genotype, Epclusa offers physicians in China an important new option for effectively treating their patients while potentially helping to reduce the significant burden of HCV at a population level,” said John F. Milligan, Gilead’s President and Chief Executive Officer. “Gilead has now launched two direct-acting antiviral treatments in China, and we are committed to supporting efforts to screen and link patients to treatment, to help address the country’s HCV epidemic.”
Epclusa received marketing approval from the U.S. Food and Drug Administration (FDA) and the European Commission in 2016 as the first pan-genotypic STR for HCV infection. It is also approved for use in 54 countries.