FDA grants EUA to Lilly’s bebtelovimab for Covid-19 treatment

The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) to Eli Lilly and Company’s bebtelovimab to treat mild-to-moderate Covid-19.

Bebtelovimab is a neutralising IgG1 monoclonal antibody that is directed against the SARS-CoV-2 virus’ spike protein.

Under the FDA EUA, the antibody is indicated to treat mild-to-moderate Covid-19 in adults and paediatric patients aged 12 years and above.

It is intended for patients at an increased risk of disease progression, including hospital admission or mortality, and for people without any substitute FDA-approved or authorised Covid-19 therapy options that are not available or clinically appropriate. 

The authorised dosage is 175mg of bebtelovimab administered intravenously over a minimum of 30 seconds. 

The EUA is based primarily on analyses from the randomised Phase II BLAZE-4 clinical trial. In the trial, subjects with mild-to-moderate Covid-19 in the non-hospital setting received 175mg bebtelovimab alone or along with 700mg bamlanivimab plus 1,400mg etesevimab. 

Bebtelovimab demonstrated to retain full neutralising activity against the Omicron variant of the SARS-CoV-2 virus in pseudovirus and authentic virus testing.

Furthermore, in pseudovirus testing, bebtelovimab showed to neutralise various other viral variants, including BA.2.

Eli Lilly chief scientific and medical officer Daniel Skovronsky 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. 

“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 latest development comes after Lilly signed an agreement with the US Government to supply up to 600,000 doses of bebtelovimab for nearly $720m.