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news.The European Medicines Agency (EMA) has accepted to review Gilead Sciences' marketing authorization application (MAA) for fixed-dose combination of sofosbuvir (SOF) 400mg and velpatasvir 100 mg (VEL) to treat chronic hepatitis C infection.
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The data supporting the application was generated in the four Phase 3 Astral clinical trials. Of the 1,035 patients treated with SOF/VEL for 12 weeks, 1,015 achieved the primary efficacy endpoint of SVR12.
Under the Astral-4 trial, 267 patients were randomized with decompensated cirrhosis (Child-Pugh class B) to receive 12 weeks of SOF/VEL with or without ribavirin (RBV), or 24 weeks of SOF/VEL.
The company said 94% of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83% and 86% of subjects who received SOF/VEL for 12 weeks and 24 weeks, respectively, achieved SVR12.
The EMA will conduct the review under the centralized licensing procedure, which, if authorized, provides marketing authorization in all 28 member states of the European Union (EU), Norway and Iceland.
If approved, SOF/VEL is expected to be available for marketing in the EU in 2016. Gilead has also submitted a regulatory application for SOF/VEL in the US.
Gilead Sciences executive vice president of research and development and chief scientific officer Norbert Bischofberger said: "Despite advances in the treatment of HCV, there is a need for simple, highly effective pan-genotypic therapies, particularly for patients with genotype 3 HCV infection, who traditionally have been more difficult to cure.
"If approved, SOF/VEL 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."