|Delayed - 06/11 04:00:00 pm|
Vir Biotechnology : GSK and Vir Biotechnology announce the start of the EMA rolling review of VIR-7831 (sotrovimab) for the early treatment of COVID-19
|05/10/2021 | 04:59am|
- Rolling review will evaluate sotrovimab in adults and adolescents with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19
- Review will support a formal Marketing Authorisation Application
- GSK and Vir continue discussions with global regulators to make sotrovimab available to patients with COVID-19
The EMA will evaluate all data on sotrovimab, including evidence from clinical trials, as they become available. The rolling review will continue until enough evidence is available to support a formal marketing authorisation application. The EMA will assess the medicine's compliance with the usual standards for efficacy, safety and quality. While the overall review timeline cannot be forecast yet, the process should be quicker than a regular evaluation due to the time gained during the rolling review.
The review of the data is being carried out by the
Separately, the CHMP is also reviewing sotrovimab under Article 5(3) of Regulation 726/2004 and is expected to provide EU-wide recommendations for national authorities who may take evidence-based decisions on the early use of the medicine, ahead of any formal Marketing Authorisation.
Sotrovimab is an investigational compound and has not been granted a marketing authorisation anywhere in the world.
An Emergency Use Authorization (EUA) application for sotrovimab has been submitted to the
The multi-center, double-blind, placebo-controlled, Phase 3 COMET-ICE trial investigated sotrovimab in adults with mild or moderate COVID-19 at high risk of progression to severe disease.
This Phase 3 trial evaluated the safety and efficacy of a single IV infusion of sotrovimab (500 mg) or placebo in non-hospitalised participants globally. The efficacy interim analysis included 291 patients in the treatment arm and 292 patients in the placebo arm. Among those studied, 63% were Hispanic or Latinx and 7% were Black or
In addition to the COMET-ICE trial, the full COMET clinical development program for sotrovimab includes:
- COMET-PEAK: An ongoing Phase 2 trial with two parts: to compare the safety and viral kinetics of 500 mg intramuscularly (IM) administered sotrovimab to 500 mg intravenously administered sotrovimab among low-risk adults with mild to moderate COVID-19, and to evaluate the similarity in pharmacokinetics between sotrovimab manufactured by different processes
- COMET-TAIL: A Phase 3 trial expected to begin in the second quarter of 2021 as an early treatment in high-risk adults to assess whether IM-administered sotrovimab can reduce hospitalisation or death due to COVID-19
- COMET-STAR: A Phase 3 trial expected to begin in the second quarter of 2021 in uninfected adults at high risk to determine whether IM-administered sotrovimab can prevent symptomatic infection.
Sotrovimab was also evaluated in the outpatient setting in BLAZE-4, a Phase 2 trial sponsored by
Additionally, sotrovimab, along with VIR-7832, is being evaluated in the Phase 1b/2a National Health Service-supported AGILE trial in adults with mild to moderate COVID-19. VIR-7832 is the second monoclonal antibody from the Vir-GSK collaboration to be investigated as a potential COVID-19 treatment. About Sotrovimab
Sotrovimab is an investigational dual-action 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, and less likely to mutate over time. Sotrovimab, which incorporates
VIR-7832 is an investigational dual-action SARS-CoV-2 monoclonal antibody. Preclinical data suggest it has the potential to both block viral entry into healthy cells and an enhanced ability to 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. VIR-7832, which incorporates
GSK's response to COVID-19 has been one of the broadest in the industry, with three potential treatments in addition to our vaccine candidates in development.
GSK is collaborating with several organisations on COVID-19 vaccines by providing access to our adjuvant technology. In addition to our work with Medicago, a collaboration with
GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, multi-valent mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK will also support manufacturing of up to 100m doses of CureVac's first generation COVID-19 vaccine.
GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. We are collaborating with
Vir was founded with the mission of addressing the world's most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody we advanced into the clinic. It was carefully selected for its unique characteristics demonstrated during preclinical research, including a high barrier to resistance and dual-action ability to both block the virus from entering healthy cells and clear infected cells. Sotrovimab has since demonstrated positive monotherapy results in a Phase 3 clinical trial for the early treatment of COVID-19 in high-risk adult patients, and proven in preclinical studies to retain activity against all known circulating COVID-19 variants of concern. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with our partners. About GSK
GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us. About
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company's Annual Report on Form 20-F for 2020 and any impacts of the COVID-19 pandemic. Vir Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "plan," "potential," "aim," "promising" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir's expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the timing and availability of sotrovimab to providers and patients, including arrangements with commercial payers, the timing of availability of clinical data, program updates and data disclosures related to sotrovimab, the ability of sotrovimab and VIR-7832 to treat and/or prevent COVID-19, the potential of sotrovimab in the hospitalised population, the ability of sotrovimab to neutralise the SARS-CoV-2 live virus, statements related to the planned full analysis of the COMET-ICE trial, and statements related to marketing authorisations and regulatory authorisations and approvals, including plans and discussions with the EMA, FDA,
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