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GlaxoSmithKline’s COVID-19 antibody drug has been given an emergency use authorization by the Food and Drug Administration (FDA) (GSK).
The FDA has approved Sotrovimab, an investigational monoclonal antibody therapy, to treat mild to moderate COVID-19 in adults and children aged 12 and older who are at high risk of developing severe COVID-19.
Patients who are hospitalised due to COVID-19 or who need oxygen therapy should not take the medication.
Vir Biotechnology helped GSK develop the drug.
The treatment will be available for appropriate patients in the United States “in the coming weeks,” the companies said in a separate statement. The firms also stated that they intend to file for full approval of the treatment “in the second half of 2021.”
In a study of 868 patients, GSK and Vir claimed that the drug reduced the risk of hospitalisation or death in high-risk adults by 85%.
Rash and diarrhoea were the most common mild or moderate adverse events in the treatment group.
According to the company, data from lab studies show that sotrovimab “maintains activity against all known circulating variants of concern,” though the clinical implications are unknown.
Monoclonal antibodies are proteins created in the laboratory that mimic the immune system’s ability to fight viruses.
When he was diagnosed with COVID-19 late last year, former President Trump was treated with an investigational monoclonal antibody made by Regeneron Pharmaceuticals. That treatment was approved by the FDA in late November.
The FDA has also approved another Eli Lilly treatment.