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Gilead Submits MAA for Sovaldi/velpatasvir to EMA

Gilead Sciences announced its Marketing Authorization Application for a fixed-dose combination of Sovaldi and velpatasvir for the treatment of chronic hepatitis C virus infection to the European Medicines Agency is currently under review.

The application for Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was submitted based on data from the phase 3 ASTRAL trials, which evaluated the combination regimen in patients with HCV genotypes 1 to 6.

“Despite advances in the treatment of HCV, there is a need for simple, highly effective pangenotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in a press release. “If approved, [sofosbuvir/velpatasvir] will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 98% of 1,035 patients treated with the combination regimen for 12 weeks achieved the primary efficacy endpoint of SVR12. In the ASTRAL-4 study, which was presented at The Liver Meeting 2015, 94% of patients who received sofosbuvir/velpatasvir plus ribavirin for 12 weeks achieved an SVR12, as well as 83% of patients who received sofosbuvir/velpatasvir for 12 weeks and 86% of patients who received sofosbuvir/velpatasvir for 24 weeks.

Disclosure: Bischofberger is employed by Gilead Sciences.

Gilead Sciences announced its Marketing Authorization Application for a fixed-dose combination of Sovaldi and velpatasvir for the treatment of chronic hepatitis C virus infection to the European Medicines Agency is currently under review.

The application for Sovaldi (sofosbuvir, Gilead Sciences) and velpatasvir (Gilead Sciences) was submitted based on data from the phase 3 ASTRAL trials, which evaluated the combination regimen in patients with HCV genotypes 1 to 6.

“Despite advances in the treatment of HCV, there is a need for simple, highly effective pangenotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure,” Norbert Bischofberger, PhD, executive vice president of research and development and chief scientific officer at Gilead Sciences, said in a press release. “If approved, [sofosbuvir/velpatasvir] will represent a significant step forward in the potential to control and eliminate hepatitis C, as the first and only fixed-dose regimen offering high SVR rates with just 12 weeks of treatment for patients with all HCV genotypes.”

In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 98% of 1,035 patients treated with the combination regimen for 12 weeks achieved the primary efficacy endpoint of SVR12. In the ASTRAL-4 study, which was presented at The Liver Meeting 2015, 94% of patients who received sofosbuvir/velpatasvir plus ribavirin for 12 weeks achieved an SVR12, as well as 83% of patients who received sofosbuvir/velpatasvir for 12 weeks and 86% of patients who received sofosbuvir/velpatasvir for 24 weeks.

Disclosure: Bischofberger is employed by Gilead Sciences.