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Vir Biotechnology receives AustralianTGA marketing approval for sotrovimab to treat Covid-19

San Francisco
Wednesday, August 25, 2021, 14:00 Hrs  [IST]

Vir Biotechnology announced the first marketing authorization, granted in Australia, for its first commercial product, sotrovimab, developed in partnership with GlaxoSmithKline (GSK). This announcement follows news shared by GSK Australia that the Australian Therapeutic Goods Administration (TGA) has granted provisional marketing authorization for sotrovimab (under the brand name, Xevudy), a monoclonal antibody for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with Covid-19 who do not require initiation of oxygen due to Covid-19 and who are at increased risk of progression to hospitalization or death.

Sotrovimab is the first monoclonal antibody approved in Australia. As part of its overarching effort to address Covid-19, the Australian Government also recently announced an agreement to purchase sotrovimab, the first supply of which arrived in the country last week.

The TGA had previously granted sotrovimab a provisional determination in April, which provides a mechanism for accelerating the provisional marketing authorization of promising new medicines. This approval pathway allows companies to apply for registration of medicines for conditions with high unmet clinical need based on promising early clinical data.

Globally, sotrovimab is authorized for emergency use in the US, received a positive scientific opinion from the Committee for Human Medicinal Products (CHMP) in the European Union (EU), and has been granted temporary authorization in Bahrain, Canada, Egypt, Italy, Kuwait, Qatar, Singapore and the United Arab Emirates.

George Scangos, Ph.D., chief executive officer of Vir, said: “The provisional approval of sotrovimab in Australia marks an important milestone for Vir, as it is the first marketing authorization of our first commercial product. It also represents an important step forward in the Australian Government’s efforts to combat the pandemic and prevent the most severe effects of Covid-19, particularly in the face of new and emerging variants. We eagerly anticipate additional regulatory decisions around the world in the coming months and look forward to working with our partner, GSK, to expand patient access to a much-needed treatment option that continues to demonstrate, in vitro, its ability to retain activity against the tested, currently circulating variants of concern and interest, including Delta and Delta Plus.”

The regulatory applications currently under assessment around the world, include results of the phase 3 COMET-ICE (Covid-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause hospitalization for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial.

In vitro data, published in bioRxiv also demonstrate that sotrovimab retains activity against currently circulating variants of concern and interest of the SARS-CoV-2 virus including Alpha (B.1.1.7), Beta (B.1.351), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2), Epsilon (B.1.427/B.1.429), Eta (B.1.525), Gamma (P.1), Iota (B.1.526), Kappa (B.1.617.1) and Lambda (C.37), as well as new variants from Bristol (B.1.1.7+E484K) and Cameroon (B.1.619), which predominantly includes both N440K and E484K mutations that may lead to reduced activity for other neutralizing monoclonal antibodies against the SARS-CoV-2 virus.

This announcement is part of collaboration between Vir and GSK, signed in April 2020, to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes Covid-19. GSK is responsible for the commercial marketing of sotrovimab around the world.

Sotrovimab is an investigational SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and clear infected cells. The antibody binds to an epitope on SARS-CoV-2 that is shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor’s Xtend technology, also has been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

 

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