ViiV's Dovato wins speedy US approval with PRV, empowering GSK to muscle into Gilead's HIV empire
GSK’s ViiV is poised to take a bite out of Gilead’s HIV empire, after its dual HIV regimen — Dovato — secured FDA approval on Monday, after the British drugmaker submitted its marketing application with a priority review voucher (PRV) last October, enabling a speedy response from the US regulator.
Dovato is an improvement over GSK’s existing two-drug regimen Juluca, which does not include a nucleoside analog reverse transcriptase inhibitor or a ‘nuke.’ This family of drugs are used to thwart an enzyme called reverse transcriptase, which is used by the HIV virus to make copies of itself inside a healthy cell.
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