The United States government has announced plans to purchase sotrovimab, an investigational monoclonal antibody used for the early treatment of COVID-19, according to a press release from drug makers GlaxoSmithKline (GSK) plc and Vir Biotechnology, Inc. The contracts total about $ 1 billion, according to the press release.
“Given the large number of patients who continue to become ill with COVID-19 in many parts of the United States, there is a continued need for access to effective treatments. We are proud to work with the US government to help make sotrovimab available to them. patients. ”, Said Dr. Hal Barron, Scientific Director and President of R&D of GSK, in a press release.
Sotrovimab received Emergency Use Clearance (EUA) from the United States Food and Drug Administration (FDA) in May 2021. Under the EUA, the investigational monoclonal antibody SARS-CoV-2 in Single-dose intravenous infusion can be used to treat moderate COVID-19 in adults and children 12 years of age and older, who have tested positive for COVID-19, and are at high risk of developing severe cases of COVID-19 resulting in hospitalization or death, according to the FDA website.
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“This gives patients a real head start in the fight against the virus,” Bart Murray, vice president of COVID Therapeutics at GSK, told Fox News.
Murray told Fox News that patients who test positive for Covid-19 should be aware of this treatment and should ask their doctors if it is right for them, especially if they have an underlying disease or are immunocompromised.
“People should know that there are very effective treatments available for high-risk patients – and shouldn’t hesitate to ask their doctor for treatment,” Murray told Fox.
The use of sotrovimab is not permitted in all cases. According to the FDA website, sotrovimab is not authorized for people hospitalized due to COVID-19 or requiring oxygen therapy due to COVID-19. It is also not indicated in patients who require an increase in basal oxygen flow due to COVID-19 (in those on chronic oxygen therapy due to an underlying comorbidity unrelated to COVID-19). , the health agency said on the website. The FDA also claims that monoclonal antibodies to SARS-CoV-2 may be associated with worse clinical outcomes when given to hospital patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.
Final published data from the phase III COMET-ICE trial involving 1057 participants showed that sotrovimab reduced hospitalization and the risk of death by 79% in adults with mild to moderate COVID-19 who are at risk. high progression to serious illness on day 29 compared to placebo, according to a press release from the companies.
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The release noted that in vitro data suggested that sotrovimab maintains activity against the Delta variant and other monitored variants.
The companies also announced that data from the Phase III COMET-Tail study suggested that injecting Sotrovimab into a patient’s muscle was just as effective as giving it intravenously in high-risk populations.
Barron said this potentially offers a more convenient option for patients with Covid-19, the statement said.
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GSK officials told Fox News they will provide these doses to the US government by December 17, 2021, expanding national access to sotrovimab for patients. “With the peak winter months ahead, the supply is timely,” Murray said in an interview with Fox News.
Murray explained in the interview that the treatment is free for those who are eligible for therapy, thanks to the government contract.
“Getting the vaccine is important – but if you still get the virus, you still have the option of getting the antibodies for free.”