Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.ViiV Healthcare has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the single-pill regimen combining dolutegravir, abacavir and lamivudine, to treat HIV infection.
Subscribe to our email newsletter
The new regulatory submission follows the Japanese approval of dolutegravir as Tivicay tablets 50mg in March 2014.
In the approved regions, the single-pill dolutegravir-based regimen is called as Triumeq.
It is the company’s first fixed-dose once-daily tablet that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
ViiV Healthcare Japan president Hirohisa Iriyama said: "While there have been great improvements in HIV treatment options, there are still medical needs that cannot be met.
"ViiV Healthcare is committed to delivering new options for care and treatment for people who are living with HIV in Japan and today’s application is an important step to fulfil this commitment."
Triumeq was approved by the US Food and Drug Administration (FDA) in August 2014 and secured marketing authorisation from the European Commission (EC) in September 2014.
The FDA and EC approval are based primarily upon data from two clinical trials: including the Phase III trial (SINGLE) of treatment-naïve adults, conducted with dolutegravir and abacavir/lamivudine as separate pills.
The second is a bioequivalence study of the fixed-dose combination of abacavir, dolutegravir and lamivudine when taken as a single pill compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.