According to the company, the CHMP positive opinion of Triumeq (dolutegravir/abacavir/lamivudine) is based upon data from two major studies.
The first study is a Phase III trial of dolutegravir (SINGLE), carried out with dolutegravir and abacavir/lamivudine as separate pills.
Second is a separate bioequivalence trial of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.
ViiV Healthcare chief scientific and medical officer John Pottage said the CHMP positive opinion takes the company a step closer to bringing physicians and people living with HIV a dolutegravir based regimen that can be taken once-daily as a single-tablet.
"This opinion supports the potential of dolutegravir based regimens, as well as the importance of our ongoing research into additional single-tablet treatment options," Pottage said.
The CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), and a final decision by the EC is expected during the third quarter of 2014.
Triumeq contains the integrase inhibitor dolutegravir, which was approved by the EMA in January 2014 under the brand name Tivicay.