The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Eli Lilly’s bebtelovimab, an antibody to treat the Omicron variant.
This allows the drug to be used to treat adults with mild-to-moderate COVID-19, and children aged 12 or older, in specific emergency cases in non-hospital settings.
Patients must have had a positive SARS-CoV-2 viral test and be at high risk of developing severe COVID-19 that could lead to hospitalisation or death.
The FDA decision was based on results from the phase 2 BLAZE-4 clinical trial where non-hospitalised patients with mild-to-moderate COVID-19 either received bebtelovimab alone or a combination of bamlanivimab and etesevimab.
The trial showed that bebtelovimab retained full neutralising activity against Omicron, while also retaining neutralisation against all other known variants of concern, including the BA.2 strain. Omicron is currently the predominant strain of COVID-19 in the US.
Daniel Skovronsky, Lilly’s chief scientific and medical officer, and president of Lilly Research Laboratories, said: “Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralising antibody that could be used to fight a highly mutated variant, should one emerge.
“With the emergence of variants such as Omicron, treatment options remain limited. [This is] another treatment option to help address the ongoing needs of patients and healthcare providers who continue to battle this pandemic.”
Lilly has an agreement in place to provide the US government with up to 600,000 doses of bebtelovimab.