One day after the United States announced a supply deal for Eli Lilly’s new COVID-19 monoclonal antibody treatment, bebtelovimab, the FDA granted it emergency use authorization.
Bebtelovimab can be used for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients, age 12 and older, who are at high risk for progression to severe COVID-19.
The treatment has been shown to be active against the omicron variant. Three weeks ago, Lilly’s antibody cocktail of bamlanivimab and etesevimab was banned by the FDA because it was shown to be ineffective against omicron. Regeneron’s antibody, REGEN-COV, also was grounded that day for the same reason.
The authorized dose of bebtelovimab is 175 mg given as an intravenous injection over at least 30 seconds. The dosage is considerably smaller and quicker to administer than previous antibody treatments approved for COVID-19.
The endorsement is based on the analyses of the phase 2 BLAZE-4 trial of nonhospitalized patients who were treated with bebtelovimab alone or together with bamlanivimab and etesevimab. Pseudovirus and authentic virus testing showed that bebtelovimab retained full neutralizing activity against omicron. In addition, the drug demonstrated neutralization against all other known variants of interest including omicron’s emerging subvariant BA.2.