ViiV Healthcare has submitted a New Drug Application to the US Food and Drug Administration seeking permission to market a single-tablet, two-drug regimen of dolutegravir and lamivudine for the treatment of HIV.
The submission is based on the global GEMINI 1 & 2 studies, which confirmed non-inferiority of the two-drug regimen against to a standard three-drug scenario.
In a pooled analysis, 91% of patients taking of the two-drug regimen had HIV-1 RNA<50 copies/mL compared with 93% of patients taking dolutegravir and two nucleoside reverse transcriptase inhibitors, tenofovir disoproxil fumarate/emtricitabine.
The percentage of patients that withdrew due to adverse events was 2% in each study arm, while pooled results show that the most common adverse events across the studies were headache, diarrhoea and nasopharyngitis.
However, drug-related adverse events were less frequent in patients taking the two-drug regimen, with data showing 18 percent versus 24 percent.
“We have now entered an exciting new era of treatments for people living with HIV,” said Deborah Waterhouse, ViiV’s chief executive. “A two-drug regimen has the potential to be an important option for many who may spend their lifetime taking drugs to control their virus.
“This regulatory submission is the next step in the two-drug regimen journey and reinforces our belief that many patients can control their disease with two drugs instead of three or more.”
The company, which is majority owned by GSK, said it used a priority review voucher to speed up the FDA’s assessment, enabling a regulatory decision within six months.
The combination is already under review in Europe, and other global regulatory submissions “are anticipated in the coming months,” ViiV noted.