Autorisation de mise sur le marché en Europe de Rukobia® (fostemsavir)

ViiV Healthcare receives Marketing Authorisation for Rukobia® (fostemsavir), a first-in-class attachmentinhibitor in combination with other antiretrovirals for the treatment of adults with multi drug-resistant HIV. Fostemsavir addresses a critical need in HIV care for those with little to no treatment options left who are at risk of further disease progression, or complications from HIV.

London, 08 February 2021 – ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (“GSK”), with Pfizer Inc. and Shionogi Limited as shareholders, announced the European Marketing Authorisation of Rukobia (fostemsavir) 600mg extended-release tablets, for use in combination with other antiretroviral (ARV) therapies for the treatment of adults with multidrug-resistant HIV-1 infection, for whom it is otherwise not possible to construct a suppressive anti-viral regimen.

Fostemsaviris a first-in-class HIV attachment inhibitor; it works by targeting the first step of the HIV lifecycle and shows no cross-resistance to other currently licensed antiretroviral classes, offering a new option to this group of people who are multidrug-resistant and at risk of disease progression and death.

Professor Carlo Federico Perno, Director, Microbiology and Diagnostic Immunology, Pediatric Hospital Bambino Gesu’, Rome said: “We’ve seen significantly improved HIV treatments becoming available over the past few decades, making HIV a manageable life-long condition. However, for some people who are living with multidrug-resistant HIV, there is an urgent need for new treatment options. In clinical trials, fostemsavir, in combination with other antiretroviral therapies, demonstrated sustained rates of virologic suppression and clinically meaningful CD4+ T-cell recovery offering us a long-awaited new option for this specific HIV community.”

The Marketing Authorisation Application (MAA) for fostemsaviris supported by data from the pivotal phase III BRIGHTE study, which evaluated the safety and efficacy of fostemsavir in combination with an optimised background therapy (OBT) in heavily treatment experienced (HTE) adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomised cohort, 60% (n=163/272) of individuals who received fostemsavirin addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically significant improvements to CD4+ T-cell count through Week 96.2

Deborah Waterhouse, CEO of ViiV Healthcare,said: “There have been great stridesforwardin the treatment of HIV over the last few decades, however, there still remains a small subset of people living with multi-drug resistant HIV who are at risk of having their disease progress. The Marketing Authorisation for fostemsavir marks a significant milestone, as it addresses a critical unmet need in HIV care for those with little or no treatment options left. At ViiV Healthcare, through our pioneering research and development, we aim to meet the diverse needs of the HIV community. We won’t stop until our research offers more ways to treat, and hopefully one day, cure HIV.”

The most commonly seen treatment emergent adverse reactions were diarrhoea (24%), headache (17%), nausea (15%), rash (12%), abdominal pain (12%), and vomiting (11%). The most common adverse events leading to discontinuation were related to infections (3%). The most serious adverse reaction was immune reconstitution inflammatory syndrome.

Fostemsavir, under the brand name Rukobia, was licensedby the US Food and Drug Administration on 2 July 2020, and further regulatory applications have been submitted worldwide.

As the only pharmaceutical company solely focused on HIV and AIDS, ViiV Healthcare is working to deliver a broad range of treatments that meet the needs of a wide variety of people living with HIV (PLHIV). The company continues to invest in R&D programmes that push the boundaries to provide a portfolio of innovative treatment options that will help make a difference to the lives of PLHIV.

About Rukobia (fostemsavir)

Fostemsaviris a first-in-class HIV-1 attachment inhibitor. After oral administration, fostemsavir is converted to temsavir, which is then absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. As fostemsavir is the first ARV therapy to target this step of the viral cycle, there is no demonstrated resistance to other classes of ARVs, which may help patients whose HIV infection has become resistant to most other medicines

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