David Takes on Goliath: AbbVie Poised to Disrupt Gilead’s HCV Dominance
22 Dec 2016
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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