BioCentury
ARTICLE | Company News

ViiV's dolutegravir gets Priority Review

February 16, 2013 1:30 AM UTC

FDA accepted and granted Priority Review to an NDA from ViiV Healthcare Ltd. for dolutegravir to treat HIV infection in patients ages 12 and over. The PDUFA date is Aug. 17. ViiV submitted regulatory applications for the HIV integrase inhibitor in the U.S., EU and Canada in December. The applications included data from the Phase III VIKING-3 and SAILING trials in treatment-experienced patients, as well as data from the Phase III SPRING-2 and SINGLE trials in treatment-naïve patients (see BioCentury Extra, Dec. 17, 2012). ...