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Sovaldi, velpatasvir combination for hepatitis C granted priority review by FDA

Gilead Sciences announced that the FDA granted priority review for their New Drug Application (NDA) for investigational, once-daily combination therapy of Sovaldi and velpatasvir for the treatment of chronic hepatitis C (HCV) infection, genotypes 1-6. FDA has set a target action date of June 28, 2016.

Sovaldi is a nucleotide analogue polymerase inhibitor, and velpatasvir is a pan-genotypic NS5A inhibitor. The fixed-dose combination therapy was investigated in the four Phase 3 ASTRAL trials. A marketing application is also under review in the European Union.

Sovaldi was approved by the FDA back in 2013. It is also used in the combination therapy, Harvoni (Sovaldi + ledipasvir), which was approved by the FDA in 2014.

While this latest combination drug has been designated Breakthrough Therapy, which is granted to investigational ddrugs that may offer major advances in treatment over current options, it’s important to note that it is an investigational treatment and the safety and efficacy have not yet been established.

  1. Dennis M. FDA grants priority review to Gilead's filing for Sovaldi, velpatasvir combination for hepatitis C. FirstWord Pharma. January 5, 2016. Available at: