Posted by Michael Wonder on 14 Sep 2018
ViiV Healthcare submits regulatory application to EMA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV
14 September 2018 - ViiV Healthcare today announced submission of a marketing authorisation application to the EMA 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 1,400 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.
A new drug application to the US FDA is planned for this single tablet regimen for October, using a priority review voucher. Other global regulatory submissions of dolutegravir and lamivudine as a single-tablet, two-drug regimen for HIV-1 therapy are anticipated in the coming months.
