New Anti-SARS-CoV-2 Monoclonal Antibody Found Effective Against Omicron

Indiana-based Eli Lilly and Company reported on February 3, 2022, it recently submitted a request for Emergency Use Authorization to the U.S. FDA for bebtelovimab, an investigational anti-SARS-CoV-2 Monoclonal Antibody (mAbs).

Bebtelovimab, which neutralizes the SARS-CoV-2 spike glycoprotein receptor-binding domain-specific antibody, is being evaluated to treat mild-to-moderate COVID-19 in adults and pediatric patients 12 years of age and older.

Lilly's recent financial disclosure says 'authentic virus analysis of bebtelovimab confirmed earlier pseudovirus findings, which demonstrated bebtelovimab neutralizes coronavirus variants of concern, including Omicron.'

The U.S. NIH's OpenData Portal Therapeutic Activity Explorer separately confirmed bebtelovimab's effectiveness against Omicron as of February 3, 2022.

Previously, bebtelovimab's co-creator AbCellera confirmed on January 9, 2022, this innovative mAbs maintains both full and potent neutralization activity against the Omicron variant and all other known SARS-CoV-2 variants of concern.

Lilly's bebtelovimab authorization request is vital since current demand in the U.S. surpasses mAbs supply.

This availability imbalance was recently increased when two mAbs authorizations were 'Paused' by the FDA on January 24, 2022. 

Since September 24, 2021, the U.S. government has distributed over 3 million mAbs.

Eli Lilly and Company is in Indianapolis, Indiana, and recognized U.S. revenue of $1.029 billion from COVID-19 antibodies in the fourth quarter of 2021, compared to about $850 million in 2020.

Lilly's bamlanivimab and etesevimab, administered together, were authorized by the FDA as the first and only neutralizing antibody therapy for emergency use in COVID-19 patients under 12.

In addition, the FDA accepted an sNDA from Lilly and granted priority review for baricitinib for the treatment of COVID-19.

New guidelines released by the World Health Organization on treatments for COVID-19 strongly recommend the use of baricitinib in combination with corticosteroids for severely or critically ill hospitalized COVID-19 patients.