The UK pharmaceutical company GlaxoSmithKline (GSK) and and its US partner Vir Biotechnology have submitted an application to the US Food and Drug Administration (FDA) for an expanded emergency use authorization (EUA) of their COVID-19 intramuscular antibody treatment sotrovimab, the two companies announced on Thursday
WASHINGTON (Pakistan Point News / Sputnik - 13th January, 2022) The UK pharmaceutical company GlaxoSmithKline (GSK) and and its US partner Vir Biotechnology have submitted an application to the US food and Drug Administration (FDA) for an expanded emergency use authorization (EUA) of their COVID-19 intramuscular antibody treatment sotrovimab, the two companies announced on Thursday.
"GlaxoSmithKline plc and Vir Biotechnology, Inc. today announced the submission of an application to the US Food and Drug Administration requesting an amendment to the Emergency Use Authorization for sotrovimab, an investigational monoclonal antibody for the early treatment of COVID-19, to include intramuscular (IM) administration," the companies said in a press release.
In May, FDA granted an EUA to sotrovimab, a single-dose intravenous infusion monoclonal antibody treatment of COVID-19, for use in adults with mild-to-moderate COVID-19 symptoms and for children aged 12 and older who weigh at least 40kg and are at high risk for progression to severe forms of the disease.
Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy due to the COVID-19, the release said.
On Tuesday, the two companies announced the US government will purchase an additional 600,000 doses of sotrovimab that will be delivered in the first quarter of 2022.
