US FDA approves Lilly’s antibody drug ‘bebtelovimab’ against Omicron

The United States Food & Drug Administration (FDA) has granted emergency use authorization (EUA) to an antibody drug, dubbed bebtelovimab, developed by American pharmaceutical giant, Eli Lilly & Company to combat the Omicron variant.

The company claims that its new antibody drug showcases neutralization capabilities against Omicron by binding the IgG1 monoclonal antibody to an epitope located within the SARS-CoV-2 spike protein’s receptor binding domain.

As per the EUA granted by the U.S. FDA, bebtelovimab will be given in compliance to the authorized dosage of 175mg via intravenous injection for minimum 30 seconds.

Reportedly, the federal agency has permitted the use of bebteovimab for treating mild-to-moderate Covid-19 symptoms in pediatric patients – comprising of 12 years and above individuals with at least 40 kilos of body weight – and adults.

Individuals with higher susceptibility to hospitalization and death, and risk for progression to fatal diseases will also be eligible for the antibody drug dose.

Moreover, bebtelovimab can be given to people lacking accessibility to alternative Covid-19 treatments that have been FDA approved.

Essentially, the antibody drug has displayed successful results in neutralizing the highly infectious and vaccine evading Omicron variant.

The opportune FDA approval comes following a ban announced by the regulator on Lilly’s antibody blend of etesevimab and balanivimab three weeks ago due to its ineffectiveness against Omicron.

Additionally, the federal body demolished hopes for commercialization of Regeneron’s REGEN-COV due to the same reason.

The U.S. FDA issued EUA based on the Phase 2 assessment, which was a randomized clinical trial conducted to determine effectiveness of the treatment in non-hospitalized Covid-19 patients with mild-moderate symptoms.

After systematically performing the pseudovirus and authentic virus testing, bebtelovimab was observed to have a complete neutralizing effect on Omicron variant, while the pseudovirus testing also demonstrated neutralization capabilities against all variants of interest as well as of concern, like BA.2.

Besides, the U.S. government has inked a $720 million worth deal with Lilly to distribute 600,000 doses of bebtelovimab.

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