GlaxoSmithKline HIV treatment gets European Commission marketing approval
GlaxoSmithKline's investee company, ViiV Healthcare, has received European Commission marketing authorisation for Dovato, which treats HIV-1 in adults and adolescents.
Dovato is a two-drug regimen of dolutegravir and lamivudine contained in a single, once-daily pill that would represent a simplification of standard European treatment of HIV.
Deborah Waterhouse, chief executive of ViiV, said: "For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based two-drug regimen development programme challenges this, and 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."
The authorisation was won on the basis of studies involving more than 1,400 adults with HIV-1, which demonstrated that the drug was no less effective than the standard three-drug regimen.
Dovato was authorised by the US Food and Drug Administration in April, and further regulatory applications have been submitted worldwide.
ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline, its majority owner, and Pfizer, with the venture dedicated to advancing treatment and care for people with HIV.