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ViiV Healthcare

ViiV Healthcare secures FDA approval for Rukobia combo in multidrug-resistant HIV-1

ViiV Healthcare, the HIV specialist majority owned by GSK which also counts Shionogi and Pfizer among its shareholders, has secured FDA approval for a 600mg extended-release tablet formulation of Rukobia (fostemsavir) in the treatment of HIV-1, it has emerged.

The indication relates specifically to the treatment of heavily treatment-experienced (HTE) patients with multidrug-resistant disease –approximately 6% of adult HIV patients receiving treatment – for whom their current antiretroviral (ARV) regimen is not proving effective.

Japan welcomes approval of ViiV's Dovato for HIV-1

Japan’s Ministry of Health, Labour and Welfare (MHLW) has awarded marketing approval to ViiV Healthcare, a subsidiary of GSK, for its once-daily pill Dovato (dolutegravir 50 mg/lamivudine 300 mg) for the treatment-naïve HIV-1 infection in patients of at least 12 years old who weigh at least 40kg.

Data drawn from over 1,400 HIV-1 patients and submitted to the MHLW showed that Dovato proved non-inferior compared to the combination of dolutegravir and two NRTIs, tenofovir disoproxil fumarate/emtricitabine, in plasinma HIV-1 RNA <50 copies per millilitre (c/mL) at 48 weeks of treatm

GSK's two drug HIV regimen effective when administered every two months

GSK’s long-acting, two-drug HIV regimen was as effective in supressing patient’s viral loads when administered every two months (eight weeks), than it was when administered monthly, over a period of 48 weeks, according to the results of a Phase 3 trial.

GlaxoSmithKline’s HIV unit ViiV Healthcare has said its two drug cocktail of cabotegravir and rilpivirine (Janssen) proved successful in supressing viral load when administered every two months in the Phase 3 ATLAS-2M.

ViiV's Dovato approved in Europe as treatment option for HIV-1

ViiV Healthcare, the specialist HIV firm majority owned by GSK, is celebrating the news that the European Commission has chosen to approve Dovato (dolutegravir/lamivudine) as a treatment for HIV-1 infection.

The marketing authorisation applies to patients over the age of 12 who also weigh at least 40kg and have no known or suspected resistance to the integrase inhibitor class, or lamivudine.

ViiV Healthcares scores first twin-drug FDA approval for untreated HIV-1

ViiV Healthcare, the pharmaceutical firm owned by Shionogi, Pfizer and predominantly GSK, has announced its two-drug HIV regimen Dovato (dolutegravir and lamivudine) has secured FDA approval for the treatment of HIV-1 infection.

The approval was given specifically in adult patients with no antiretroviral treatment history and with no known or suspected substitutions associated with resistance to individual components of the regimen, making it the first FDA-approved two-drug regimen of its kind.

Janssen and ViiV's monthly injectable HIV combo proves non-inferior to daily standard of care

Janssen and GSK’s ViiV Healthcare have unveiled strong new Phase 3 data on its two-drug regimen, injected once a month, for the treatment of HIV-1, demonstrating similar efficacy to a standard daily, oral three-drug regimen over a 48 week period, meeting its primary endpoint.

It was shown that HIV patients who had maintained viral suppression for at least six months, on a daily oral regimen comprised of two nucleoside reverse transcriptase inhibitors (NRTIs) plus a third agent, maintained similar rates of viral suppression taking the combination of Janssen’s rilpivirine and ViiV’s

ViiV's two-drug regimen gets EU approval for HIV-1

ViiV Healthcare has announced that its HIV therapy Juluca (dolutegravir/rilpivirine) has been awarded marketing authorisation in the EU from the European Commission, making it the first available two-drug regimen, daily single pill solution for the type 1 of the virus (HIV-1).

FDA approves Gilead's Biktarvy for HIV as Viiv Healthcare launches patent lawsuit

Gilead has announced that its daily single-tablet therapy Biktarvy has received FDA approval for HIV-1 infection.

FDA approves first-ever two-drug HIV regimen, GSK's Juluca

GlaxoSmithKline has announced that the FDA has awarded US marketing authorisation to the first two-drug regimen in the treatment of HIV.

Juluca, as the therapy is known, is a combination of dolutegravir – an integrase inhibitor from GSK’s majority-owned ViiV Healthcare – and rilpivirine, a non-nucleoside reverse transcriptase inhibitor developed by Johnson & Johnson. It will be available to patients who have been on a stable treatment regimen for at least six months.

Monthly injectable HIV treatment proves as effective as traditional daily pill regimen

New early trial data suggests that current daily HIV pill regimens could be replaced with injections which slowly release medication for the virus over time. This new method has been found to be as successful as current treatment plans and could provide the same benefits in just six injections annually.

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