Posted by Michael Wonder on 19 Oct 2018
ViiV Healthcare submits new drug application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
18 October 2018 - Priority review voucher used with submission with anticipated target action date of six months.
ViiV Healthcare today announced it has submitted a new drug application to the US FDA for a single-tablet, two-drug regimen of dolutegravir and lamivudine for the treatment of HIV-1 infection.
The submission is based on the global GEMINI 1 & 2 studies that included more than 1400 HIV-1 infected adults with baseline viral loads up to 500,000 c/mL. The results of these studies were presented at the 2018 International AIDS Society meeting in July.
