The drug bebtelovimab, manufactured by Eli Lilly, has been authorized to treat mild to moderate cases of the coronavirus in people who are at high risk for hospitalization and death, according to the FDA.
The drug, which is meant to be given early after a positive COVID-19 test, has not been authorized for patients who are hospitalized or require oxygen therapy because of COVID-19.
Eli Lilly has revealed that it has made a deal to supply the U.S. government with 600,000 doses of the drug for at least $720 million to be delivered by March 31.
"This purchase will add an additional 600,000 courses of treatment to our nation's 'medicine cabinet' that could help prevent severe outcomes for Americans who do get sick with COVID-19," Health Secretary Xavier Becerra said in a statement.
"Our top priority is preventing people from getting sick in the first place, which is why it is critical that Americans continue to get vaccinated and get their booster shot as soon as they're eligible."
Testing of the drug in the laboratory has shown that it has full neutralizing activity against the Omicron variant and other variants of interest and concern, including Omicron subvariant BA.2.
The news of the approval comes after other monoclonal antibody treatments, including another made by Lilly called bamlanivimab/etesevimab and another made by Regeneron, were not effective in treating illness caused by the Omicron variant.
The FDA removed the previous Lilly treatments and the one by Regeneron from a list of treatments for COVID-19 in January. Removing them from the list of authorized treatments avoids exposing patients to side effects.
The Biden administration also recently purchased 600,000 additional doses of a monoclonal antibody treatment made by GlaxoSmithCline and Vir Biotechnology -- which has been in short supply after it became the dominant treatment when the emergence of the Delta and Omicron variants rendered others ineffective.