20 January 2020 | News
Dovato (dolutegravir 50 mg/lamivudine 300 mg) gets approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg
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ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, announced that it has obtained approval of Dovato (dolutegravir 50 mg/lamivudine 300 mg) from the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, to be administered orally, with or without food.
Dovato is a once-daily, single-pill, 2-drug regimen (2DR) for treatment-naïve HIV-1 infection that combines dolutegravir, an integrase inhibitor (INI), with the nucleoside reverse transcriptase inhibitor (NRTI) lamivudine.
Dustin Haines, President, ViiV Healthcare Japan said: “In Japan, the standard of care for treatment-naïve people living with HIV has been for many years with a three-drug regimen. The data from our dolutegravir-based 2-drug regimen development programme has, however, challenged this, and with the authorisation of Dovato, people living with HIV in Japan can, for the first time, start treatment on a once-daily, single-pill, 2-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen.”
Dr. Ichiro Koga, MD, Director Medical Affairs, ViiV Healthcare Japan said: “The authorisation of Dovato in Japan marks a significant development for people living with HIV. This treatment allows individuals to take a 2-drug regimen in a once-daily, single-pill with dolutegravir at its core. ViiV Healthcare’s ambition and innovative R&D programme aims to reduce the number of HIV medicines people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to help support this aim.”