January 20, 2017
European Medicines Agency Validates Gilead’s Marketing Authorization Application for Investigational Chronic Hepatitis C Therapy Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX)
– SOF/VEL/VOX Granted an Accelerated Assessment by the
“Direct-acting antiviral treatments have transformed our ability to
treat hepatitis C; however, for some patients who have failed to achieve
a cure with these regimens, effective and well-tolerated therapies are
still needed,” said
The MAA for SOF/VEL/VOX is supported by data from two Phase 3 studies (POLARIS-1 and POLARIS-4), which evaluated 12 weeks of the fixed-dose combination in direct-acting antiviral (DAA)-experienced patients with hepatitis C genotypes 1-6, including those who failed prior treatment with an NS5A inhibitor-containing regimen. Across the two studies, 97 percent of patients treated with SOF/VEL/VOX (n=430/445) achieved the primary efficacy endpoint of SVR12. The MAA also includes data from two additional phase 3 studies (POLARIS-2 and POLARIS-3), which evaluated 8 weeks of SOF/VEL/VOX in 611 DAA-naïve patients with genotypes 1-6. In POLARIS-3, 96 percent of patients with genotype 3 infection and cirrhosis treated with SOF/VEL/VOX (n=106/110) achieved the primary efficacy endpoint of SVR12. The most common adverse events among patients who received SOF/VEL/VOX were headache, fatigue, diarrhea and nausea.
SOF/VEL/VOX for the treatment of HCV will be reviewed by the EMA under
the centralized licensing procedure for all 28 member states of the
SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the risk
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Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Mark Snyder, 650-522-6167