China's NMPA approves new hepatitis drug Vosevi

The Chinese National Medical Products Administration (NMPA) has approved Vosevi (sofosbuvir 400mg/velpatasvir 100mg/voxilaprevir 100mg), a once-daily single-tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection in adults without cirrhosis or with compensated cirrhosis who have failed prior treatment with a direct-acting antiviral (DAA) therapy, from US biotech major Gilead Sciences (Nasdaq: GILD), whose share moved 2.4% higher to $66.85 om Friday following the announcement.

The approval of Vosevi in China is supported by two global Phase III studies, POLARIS-1 and POLARIS-4, which evaluated 12 weeks of treatment with Vosevi among adults with HCV genotype 1-6 with or without compensated cirrhosis who had failed prior DAA treatment with or without an NS5A inhibitor. Across POLARIS-1 and POLARIS-4, 97% of patients treated with Vosevi (n=431/445) achieved SVR12, the primary endpoint to determine cure rate, defined as HCV RNA undetectable 12 weeks after completing therapy.

“People who have not achieved HCV cure with direct acting antiviral medicines are often faced with limited choices for re-treatment,” said Professor Lai Wei, director of the Hepatology and Pancreatic Center, Tsinghua University-affiliated Beijing Tsinghua Changgung Hospital. “With high cure rates across all genotypes, Vosevi is a promising option for people who require a new regimen to potentially achieve an HCV cure,” he added.