Dolutegravir/lamividune FDC submitted to EMA and FDA
On 17 October 2018, ViiV healthcare announced that the dual-drug fixed dose combination FDC) of dolutegravir/lamivudine had been submitted to the US FDA. 
Submission is based on results from the phase 3 GEMINI studies in treatment naive participants that were presented at the AIDS 2018 conference in July. [2, 3]
These results showed dolutegravir/3TC to be non-inferior to triple therapy using dolutegravir plus tenofovir-DF/emtricitabine.
The FDA submission included a priority review voucher which shortens the decision timeline to six months. These vouchers are bought and sold by companies and enable a faster review process.
The dolutegravir/lamivudine FDC was also submitted to the EMA on 14 September 2018. 
- ViiV press statement. ViiV Healthcare submits New Drug Application to US FDA for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. (17 October 2018).
- Cahn P et al. Non-inferior efficacy of dolutegravir (DTG) plus lamivudine (3TC) versus DTG plus tenofovir/emtricitabine (TDF/FTC) fixed-dose combination in antiretroviral treatment-naïve adults with HIV-1 infection – 48-week results from the GEMINI studies. AIDS 2018, 23-27 July 2018, Amsterdam. Late breaker oral abstract TUAB0106LB.
- Collins S. DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study
- ViiV press statement. ViiV Healthcare submits regulatory application to European Medicines Agency for single-tablet, two-drug regimen of dolutegravir and lamivudine for treatment of HIV. (14 September 2018).