FDA Wants Eli Lilly and Regeneron to Assess Their COVID-19 Antibody Combos 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.

Regeneron has been tracking variants “since very early in the pandemic” and “has confirmed that the REGEN-COV antibody cocktail remains potent against the variants first identified in the UK, South Africa, Brazil and California,” a company spokesperson told FDAnews.

HHS announced early this week that it would limit distribution of Eli Lilly’s bamlanivimab, one of the antibodies receiving the revised letter, in three states because of concerns about its effectiveness against a variant strain of the virus first identified in California, CAL.20C (DID, March 16).

Lilly’s bamlanivimab received an EUA as a monotherapy in November (DID, Nov. 10, 2020), and as a combined treatment with etesevimab in February (DID, Feb. 11), while Regeneron’s combined antibody therapy, casirivimab and imdevimab, received an EUA in November (DID, Nov. 24, 2020). All three were authorized to treat patients with mild-to-moderate COVID-19 at high risk of progressing to severe COVID-19 or hospitalization.

Read the revised EUAs here: www.fdanews.com/03-16-21-EUALetters.pdf. ― Jason Scott