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news.The European Medicines Agency (EMA) has validated and is assessing Gilead Sciences’ Marketing Authorization Application (MAA) for the investigational, once-daily, single tablet regimen of sofosbuvir 400 mg, velpatasvir 100 mg and voxilaprevir 100 mg (SOF/VEL/VOX) for the treatment of chronic hepatitis C virus (HCV)-infected patients.
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Gilead Research and Development executive vice president and chief scientific officer Norbert Bischofberger said: “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.
“The submission of this application reflects our continued commitment to provide treatment options for this life-threatening disease to as many patients as possible, including those who have failed previous direct-acting antiviral therapy, in Europe and around the world.”
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 European Union, Norway and Iceland.
The review will follow an accelerated procedure reserved for medicinal products expected to be of major public health interest. Gilead also submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for SOF/VEL/VOX on December 8, 2016.
SOF/VEL/VOX is an investigational product and its safety and efficacy has not been established.