The first supplies for a potential winter surge are expected on December 17th.
According to a press release from drug manufacturers, GlaxoSmithKline (GSK) plc and Vir Biotechnology, Inc., the United States government announced plans to purchase sotrovimab, an investigational monoclonal antibody, which can be used as an early treatment for COVID-19. is done for. The total contract is about one billion. Dollar, according to the news release.
“Given the large number of patients becoming ill with COVID-19 in many regions in the US, there is an ongoing need for access to effective treatment. We are proud to work with the US government to help make sotrovimab available. patients,” GSK’s chief scientific officer and president R&D, Dr. Hal Barone, said in a news release.
Sotrovimab was granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) in May 2021. Under the EUA, investigative single-dose intravenous infusion SARS-CoV-2 monoclonal antibodies can be used for mild-to-moderate COVID-19 in adults and children 12 years of age and older who tested positive for COVID-19, and are at higher risk for developing severe cases of COVID-19, which, according to the FDA, lead to hospitalization or death. Website,
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“It gives patients a real head start in fighting the virus,” Bart Murray, vice president of COVID Therapeutics at GSK, told Granthshala News in an interview.
Murray told Granthshala News that patients who test positive for COVID-19 should be aware of this treatment and ask their doctors if it is appropriate for them, especially if they have an underlying condition or are immunocompromised. .
“People need to know that there are highly effective treatments for high-risk patients — and shouldn’t hesitate to ask their doctor to seek treatment,” Murray told Granthshala.
Sotrovimab is not authorized for use in every case. According to the FDA’s website, sotrovimab is not authorized for people who are hospitalized due to COVID-19, or who need oxygen therapy due to COVID-19. The health agency said on the website that it is also not indicated in patients who require an increase in baseline oxygen flow rate due to COVID-19 (due to their underlying non-COVID-19 related comorbidities). on chronic oxygen therapy). The FDA also says that SARS-CoV-2 monoclonal antibodies may be associated with poor clinical outcomes when hospitalized patients with COVID-19 require high-flow oxygen or mechanical ventilation. Is.
Final data released from the COMET-ICE phase III trial that included 1057 participants showed that sotrovimab reduced the risk of hospitalization and death by 79 percent in adults with mild to moderate COVID-19 who did not respond to severe during the day. are at high risk of progressing to the disease. According to a news, compared to placebo release by companies.
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In vitro data suggest that sotrovimab maintains activity against the delta variant and other surveillance variants, the release said.
The companies also announced that data from the COMET-TEL Phase III study suggested that injecting sotrovimab into patient muscles was equally effective compared to administering it intravenously in a high-risk population.
Barron said it potentially offers a more convenient option for patients suffering from COVID-19, according to release,
GSK officials told Granthshala News they would supply these doses to the US government by December 17, 2021, expanding nationwide access to sotrovimab for patients. “With the expected winter surge ahead of us in the months ahead, supplies are on time,” Murray said in an interview with Granthshala News.
Murray told during the interview that the treatment is free for those who are eligible for treatment because of the government contract.
“Getting the vaccine is important – but if you still get the virus you have the option of getting the antibodies at no cost.”