ViiV submits Priority Review voucher with HIV combo

ViiV Healthcare Ltd. (Brentford, U.K.) said it submitted regulatory applications to FDA and EMA for a single-tablet combination of Tivicay dolutegravir and Edurant rilpivirine to treat HIV-1 infection. The company said the combo is the first single-tablet regimen for HIV maintenance treatment that consists of only two therapies.

Along with the NDA, ViiV submitted a Priority Review voucher to FDA. GlaxoSmithKline plc (LSE:GSK; NYSE:GSK), ViiV's majority owner, said it purchased the voucher "recently" for $130 million. Spokesperson Sarah Spencer declined to name the seller or provide other details...