David Takes on Goliath: AbbVie Poised to Disrupt Gilead’s HCV Dominance

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On December 08 and December 19, 2016, Gilead Sciences and AbbVie, respectively, filed new drug applications (NDAs) with the FDA for their novel pan-genotypic direct acting antiviral (DAA) regimens against the hepatitis C virus (HCV). With both regimens having received Breakthrough Therapy designation, GlobalData expects the FDA to deliver a positive verdict for each drug combination during the third quarter of 2017. Despite this apparent head-to-head competition for market access, once approved, AbbVie’s 2-DAA regimen is poised to successfully challenge both of Gilead’s newest pipeline products as well as their recently approved Epclusa (sofosbuvir + velpatasvir), the first pan-genotypic DAA regimen launched in the US.

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