ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, this week said that the European Commission has granted Marketing Authorisation for HIV-1 infection treatment, Dovato.
Deborah Waterhouse, CEO, ViiV Healthcare, said that the the data from dolutegravir-based two-drug regimen development programme challenges the standard of care for treatment-naïve people living with HIV in Europe which has been a three-drug regimen.
Waterhouse said that with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals.
Marketing Authorisation for Dovato is supported by data from the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults.
The safety results for dolutegravir and lamivudine seen in GEMINI 1 and 2 were consistent with the product labelling for dolutegravir and lamivudine.
John C. Pottage, Jr, Chief Scientific and Medical Officer, ViiV Healthcare said: “The Marketing Authorisation of Dovato in Europe marks a significant development for people living with HIV. This treatment allows individuals to take a two-drug regimen in a single pill with dolutegravir at the core, building on the established potency and safety profiles of dolutegravir and lamivudine. ViiV Healthcare’s ambition and innovative R&D programme aims to reduce the number of HIV drugs people living with HIV take over a lifetime and Dovato is an important addition to our portfolio of medicines to support this aim.”