The Food and Drug Administration (FDA) has granted emergency use authorization for a COVID-19 antibody drug manufactured by GlaxoSmithKline (GSK).
Sotrovimab, an investigational monoclonal antibody therapy, has been approved for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years of age and older who are at high risk of progressing to COVID -19 severe, FDA said in a press release.
The drug is not intended for patients hospitalized due to COVID-19 or those who require oxygen therapy.
GSK developed the drug with Vir Biotechnology.
Businesses said in a separate statement that treatment will be available to appropriate patients in the United States “in the coming weeks”. The companies further said they plan to file for full treatment approval “in the second half of 2021”.
GSK and Vir said the drug reduced the risk of hospitalization or death in high-risk adults by 85% in a trial of 868 patients.
The most common adverse events in the treatment group were rash and diarrhea, which were mild or moderate.
The company also said that data from laboratory studies show that sotrovimab “maintains its activity against all known variants in circulation and of concern”, although the clinical impact of the data is not yet known.
Monoclonal antibodies are proteins made in the lab that mimic the immune system’s ability to fight viruses.
Former President TrumpDonald TrumpTrump goes wild after grand jury sits down for New York City criminal investigation Schumer lifted vote on Jan.6 commission bill Senators fight to save Jan.6 commission MORE praised an experimental monoclonal antibody made by Regeneron Pharmaceuticals that he was treated with when he contracted COVID-19 late last year. The FDA has cleared this treatment End of november.
Another treatment for Eli Lilly has also been cleared by the FDA.