Dolutegravir/lamividune FDC submitted to EMA and FDA

19 October 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

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. [1]

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. [4]

Reference

1. 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).
   https://www.viivhealthcare.com/media
2. 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.
   http://programme.aids2018.org/Abstract/Abstract/13210 (abstract)
   https://youtu.be/pgmb1Fi63Fo?t=3642 (webcast)
3. Collins S. DTG/3TC dual therapy is non-inferior to triple-ART in GEMINI study
   https://i-base.info/htb/34647
4. 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).
   https://www.viivhealthcare.com/media