30 June 2021 | News
Monoclonal Antibody Sotrovimab (VIR-7831) is currently undergoing review by the Singapore Health Sciences Authority (HSA) under the Pandemic Special Access Route (PSAR) for interim authorization
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GlaxoSmithKline Singapore and Vir Biotechnology on June 30, 2021, announced an agreement with the Government of Singapore for the supply of sotrovimab, an investigational single-dose monoclonal antibody, for the treatment of patients with COVID-19 who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19.
As variants continue to arise, vaccines together with the availability of safe and effective monoclonal antibody treatments have the potential to increase the chance of ending the pandemic. We’re committed to partnering with the government of Singapore to make this important treatment option available to its citizens and to be part of its long-term solution to manage COVID-19” said Mike Crichton, SVP Specialty and Primary Care Therapy Area, GSK.
Phil Pang, chief medical officer of Vir Biotechnology explained, “Sotrovimab was designed from the beginning to combat COVID-19 as it evolved, and, based on our most recent in vitro data, we are heartened to see that it appears to retain activity against all circulating variants of concern.”
GSK Singapore has submitted an application under the Pandemic Special Access Route (PSAR) for sotrovimab to the Health Sciences Authority of Singapore (HSA). Sotrovimab is currently undergoing regulatory review for interim authorization under the PSAR.
Preclinical data suggest sotrovimab targets a conserved epitope of the SARS-CoV-2 spike protein which is less likely to mutate over time. Data from several in vitro studies demonstrated that sotrovimab maintains activity against multiple circulating variants of concern, including the Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), and Delta (B.1.617.2) variants, based on in vitro data from live virus and pseudotyped virus assays. The clinical impact of these variants is not yet known. Data collection and analysis is still ongoing.
On 26 May, the US Food and Drug Administration (FDA) granted an Emergency Use Authorization (EUA) to sotrovimab. GSK and Vir are in discussions with other governments to explore similar supply agreements, as countries accelerate their vaccine and therapeutics programmes against COVID-19.