FDA Orders Eli Lilly, Regeneron to Evaluate COVID-19 Antibody Cocktails Against Variants

In a revision of its Emergency Use Authorizations (EUAs) for Eli Lilly’s and Regeneron’s antibody combination therapies for COVID-19, the FDA is requiring the companies to assess the therapies against the mutant strains of the SARS-CoV-2 virus.

The moves follow new evidence that variants strains, including B.1.351, which was first identified in South Africa, are resistant to antibody treatments, as noted in a study from Columbia University researchers published in Nature earlier this month.

In the revised EUA requirements, the FDA stipulates that Eli Lilly and Regeneron must “establish a process for monitoring genomic databases” for tracking new variants and send the agency a summary of their findings on a monthly basis.