ViiV Healthcare has today, 16 March, 2015, obtained approval from the Ministry of Health, Labour and Welfare (MHLW) in Japan, for Triumeq®, 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 drug was filed for approval on 15 December 2014 and will now be co-promoted in Japan by ViiV Healthcare and Shionogi & Co. The US Food and Drug Administration (FDA) approved Triumeq in August 2014, and the European Commission (EC) granted marketing authorisation in September 2014.
Today’s announcement follows the approval of dolutegravir (one of the three active ingredients) as Tivicay® tablets 50mg in Japan, exactly a year ago, in March 2014. Tivicay® was approved for the indication of HIV infection in August 2013 in the US, and in January 2014 in Europe.
Hirohisa Iriyama, Country Manager of ViiV Healthcare Japan said, ‘ViiV Healthcare is committed to delivering new treatment options for the medical needs of people living with HIV in Japan. ViiV Healthcare is very proud that today’s approval, coming just a year after the approval and subsequent launch of Tivicay®, means that we can now offer physicians and patients living with HIV in Japan the first single-pill containing dolutegravir.’
About Human Immunodeficiency Virus (HIV) infection in Japan
According to a report by the MHLW’s Committee on AIDS Trends, a total of 1,106 people were reportedly diagnosed as HIV infected (without AIDS) in 2013, at the time of HIV diagnosis 484 patients were reported to have AIDS. The total number of newly reported cases in 2013, therefore, came to be 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 23,0001.