Officials with Gilead Sciences, Inc. have announced that the Food and Drug Administration has granted priority review for an investigational, once-daily fixed-dose combination treatment for hepatitis C.
The combination treatment includes the nucleotide analog polymerase inhibitor sofosbuvir, approved as Sovaldi in December 2013, and velpatasvir, an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
The FDA has assigned the treatment a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options.
A marketing application for SOF/VEL is also under review in the European Union. Gilead filed the new drug application for the treatment on Oct. 28, 2015, and FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.