FDA Grants Gilead’s Hepatitis C Combo Drug Priority Review

The US Food and Drug Administration (FDA) has granted priority review to Gilead Sciences’ new drug application (NDA) 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. Gilead filed the NDA for SOF/VEL on October 28, 2015, and the FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of June 28, 2016.

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. A marketing application for SOF/VEL is also under review in the European Union and was validated by the European Medicines Agency (EMA) in December 2015.

Source: Gilead Sciences

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