ViiV HEALTHCARE ANNOUNCES REGULATORY SUBMISSION IN JAPAN FOR SINGLE-PILL REGIMEN COMBINING DOLUTEGRAVIR, ABACAVIR AND LAMIVUDINE FOR THE TREATMENT OF HIV
ViiV Healthcare has today, 15 December 2014, submitted a regulatory application to the Ministry of Health, Labour and Welfare (MHLW) in Japan for the single-pill regimen combining dolutegravir, abacavir and lamivudine for the treatment of HIV infection. This new regulatory submission follows the approval of dolutegravir as Tivicay® tablets 50mg in Japan, March 2014.
Known as Triumeq® where it is approved, the single-pill dolutegravir-based regimen is ViiV Healthcare’s first fixed-dose once-daily tablet that combines dolutegravir, an integrase inhibitor, with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine. The US Food and Drug Administration (FDA) approved Triumeq in August 2014 and the European Commission (EC) granted marketing authorisation in September 2014.
Hirohisa Iriyama, President of ViiV Healthcare Japan 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.”
About Human Immunodeficiency Virus (HIV) infection in Japan
According to the Report by AIDS Surveillance Committee of MHLW, in 2013 the total number of newly reported cases was 1,590 patients. The cumulative number of cases that have been reported up to 2013 (excluding cases of infections caused by coagulation factor preparations) is approximately 23,000.[1]
[1] 2013 AIDS Surveillance Committee of MHLW: http://api-net.jfap.or.jp/status/2013/13nenpo/h25gaiyo.pdf
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