Chip­ping away at Gilead­'s HIV em­pire, GSK's Vi­iV sub­mits NDA for 2-drug HIV reg­i­men -- play­ing vouch­er card for speedy FDA re­view

GSK’s am­bi­tion to cap­ture a big­ger piece of the HIV drug mar­ket from US ri­val Gilead con­tin­ues as its ma­jor­i­ty-owned Vi­iV Health­care sub­mit­ted an ap­pli­ca­tion to mar­ket it’s two-drug  treat­ment com­pris­ing do­lute­gravir (DTG) and lamivu­dine (3TC) to the FDA in tan­dem with a pri­or­i­ty re­view vouch­er (PRV), em­pow­er­ing the com­pa­ny to re­ceive a re­sponse from the US reg­u­la­tor in a faster-than-stan­dard six months.

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