According to pseudovirus and authentic virus data, bebtelovimab has shown neutralisation activity against widely circulating variant of concern, Omicron
FDA authorises Lilly’s Covid-19 drug bebtelovimab. (Credit: Myriams-Fotos from Pixabay)
Lilly has received the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its investigational antibody treatment, bebtelovimab, for mild-to-moderate Covid-19.
The drug was indicated for adults and children, aged 12 years and above, who are at high risk for Covid-19 progression and who are not eligible for alternative treatment.
With the FDA authorisation, bebtelovimab at 175mg dose strength can be administered as an intravenous injection for at least 30 seconds.
Bebtelovimab is a neutralising IgG1 monoclonal antibody (mAb). It is claimed to maintain neutralising activity across variants of concern, including the Omicron variant.
It was originally discovered by AbCellera, in partnership with the Vaccine Research Center (VRC) at the National Institutes for Allergy and Infectious Diseases (NIAID).
Lilly has licensed bebtelovimab and is responsible for its development, manufacturing, and distribution, along with bamlanivimab, which is the first monoclonal antibody therapy for Covid-19 to reach human testing.
Lilly chief scientific and medical officer Daniel Skovronsky said: “As a global pharmaceutical company, Lilly has worked hard to fight this pandemic.
“Early in 2021, prior to the identification of the Omicron variant, Lilly scientists were already working to develop bebtelovimab as a broadly neutralizing 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. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic.”
The FDA EUA was primarily supported by analysis from the BLAZE-4, a randomised, Phase 2 clinical trial in non-hospitalised patients with mild-to-moderate Covid-19.
In the trial, participants were given the authorized dose of bebtelovimab 175mg alone, or together with 700mg bamlanivimab and 1,400mg of etesevimab.
The pseudovirus and authentic virus testing showed that bebtelovimab can completely retain the neutralising activity against the Omicron variant.
Recently, Lilly signed an agreement with the US government to supply up to 600,000 doses of its investigational Covid-19 drug for no less than $720m.