FDA grants priority review to Gilead Sciences’ hepatitis C combination drug

Gilead filed a new drug application for the treatment, a combination of the company’s Sovaldi with velpatasvir, in October last year. A final decision from the FDA is expected by 28 June.

Sofosbuvir (SOF), approved as Sovaldi in December 2013, is a nucleotide analog used in combination with other drugs for the treatment of hepatitis C virus (HCV) infection.

It is a prescription medicine used with other antiviral medicines to treat chronic hepatitis C genotype 1, 2, 3, or 4 infection in adults.

Velpatasvir (VEL) is an investigational pan-genotypic NS5A inhibitor. Gilead said the SOF/VEL fixed-dose combination is an investigational product and its safety and efficacy have not been established.

The sovaldi-velpatasir combination treatment has also secured the breakthrough therapy designation, which is granted to experimental medicines that may provide major advances over existing options.

Data from four phase 3 Astral trials evaluated the fixed-dose combination in hepatitis C genotypes 1-6.

Last month, the European Medicines Agency (EMA) validated a marketing application for SOF/VEL combination.

If approved, the combination would be the first all-oral, pan-genotypic single-tablet regimen for chronic HCV infection.