Posted by Michael Wonder on 04 Jun 2017
ViiV Healthcare submits regulatory applications for the first HIV maintenance regimen comprising only two medicines
1 June 2017 - Priority review voucher submitted in US with anticipated target action date of 6 months.
GSK and ViiV Healthcare today announced regulatory submissions to the EMA and US FDA for a single-tablet, two-drug regimen of dolutegravir (Tivicay) and rilpivirine (Edurant) for the maintenance treatment of HIV-1 infection.
The submissions are based on the SWORD studies that included more than one thousand patients who previously achieved viral suppression on a three- or four-drug (integrase inhibitor, non-nucleoside reverse transcriptase inhibitor, or protease inhibitor-based) antiretroviral regimen. The results of these studies were presented at the 2017 Conference on Retroviruses and Opportunistic Infections in February.
