Gilead Submits NDA for Hepatitis C Combo DrugBy
Gilead Sciences, Inc. has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi in December 2013, and velpatasvir (VEL), an investigational pan-genotypic NS5A inhibitor, for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
The FDA has assigned SOF/VEL a breakthrough therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. Gilead plans to submit a regulatory application for approval of SOF/VEL in the European Union by the end of the year.
Source: Gilead Sciences