The European Medicines Agency (EMA) has validated Gilead Sciences‘ marketing authorisation application (MAA) for an investigational, once-daily fixed-dose combination (FDC) of sofosbuvir (SOF) 400mg and velpatasvir (VEL) 100mg to treat chronic hepatitis C virus (HCV) infection.
Sofosbuvir is a nucleotide analogue polymerase inhibitor and velpatasvir is an investigational pan-genotypic NS5A inhibitor.
Submitted in November, the MAA supports use of SOF/VEL among patients with genotype 1-6 HCV infection, including patients with compensated and decompensated cirrhosis.
Gilead Research and Development executive vice-president 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."
The application was based on data from four Phase III ASTRAL trials, which evaluated the FDC in hepatitis C genotypes 1-6.
In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 trials around 1,035 patients were treated with SOF/VEL for 12 weeks, with 1,015 achieving the primary efficacy endpoint of SVR12.
The ASTRAL-4 trial randomised 267 patients 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 noted that 94% of patients who received SOF/VEL plus RBV for 12 weeks achieved an SVR12, while 83% and 86% of patients who received SOF/VEL for 12 weeks and 24 weeks respectively achieved SVR12.
Patients treated with SOF/VEL for 12 weeks in ASTRAL-1, ASTRAL-2 and ASTRAL-3 had similar adverse events compared with placebo-treated patients in ASTRAL-1. The most common adverse events in the four ASTRAL studies were headaches, fatigue and nausea.
Currently, the FDC of SOF/VEL is granted an accelerated assessment by the EMA and it does not assure a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or final approval by the European Commission (EC).
The combination is the third investigational medicinal product from the company for HCV infection to receive accelerated assessment by the EMA.
Review of the MAA will be conducted under the centralised licensing procedure, which if approved provides marketing authorisation in all 28 member states of the EU, as well as Norway and Iceland.
If approved, SOF/VEL could be available for marketing in the EU in 2016. The company has also submitted a regulatory application for SOF/VEL in the US.