3rd Jul 2019 09:41
(Alliance News) - GlaxoSmithKline PLC on Wednesday announced the European Commission has given marketing authorisation to HIV-1 drug Dovato.
Dovato, a two-drug regimen of dolutegravir and lamivudine, was developed by ViiV Healthcare. ViiV Healthcare is an HIV specialist company in which Glaxo has a majority stake, with Prizer Inc and Shionogi Ltd also shareholders.
The marketing authorisation was granted to Dovato as a treatment for HIV-1 infection in adolescents over 12 as well as in adults. It is a new once-daily regimen consisting of a single pill containing both dolutegravir and lamivudine.
The European authorisation was given on the basis of the Gemini 1 and 2 studies, involving over 1,400 adults with HIV-1 and showing that the drug was no less effective than the standard three-drug regimen.
ViiV Healthcare Chief Executive Deborah Waterhouse said: "For many years, the standard of care for treatment-naive 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. Dovato strengthens ViiV Healthcare's industry-leading portfolio of innovative treatment approaches for people living with HIV."
Shares in Glaxo were up 1.4% at 1,642.98 pence on Wednesday morning.
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