BioCentury
ARTICLE | Clinical News

Dolutegravir regulatory update

February 18, 2013 8:00 AM UTC

FDA accepted and granted Priority Review to an NDA from ViiV 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, April 9, 2012; July 16, 2012; & Nov. 19, 2012). ...