FDA Restricts Use of 2 Monoclonal Antibody Treatments

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The U.S. Food and Drug Administration (FDA) announced Jan. 24 it is restricting the use of two monoclonal antibody treatments for COVID-19, saying data show such treatments are “highly unlikely” to be active against the Omicron variant, currently the dominant strain in the country.

Monoclonal antibodies are laboratory-created proteins that mimic natural antibodies the body produces to fight off harmful pathogens, such as the CCP (Chinese Communist Party) virus, also known as the novel coronavirus.

The agency revised its emergency authorization for the two COVID-19 treatments that come from Regeneron and Eli Lilly. Their use is now limited to when the COVID-19 patient is “likely to have been infected with or exposed to a variant that is susceptible to these treatments.”

“Because data show these treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the United States, these treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time,” the FDA stated. “In the future, if patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized in these regions.”

The Omicron variant, which started spreading in the United States in late November 2021, is estimated to account for more than 99 percent of cases in the country as of Jan. 15, according to data from the Centers for Disease Control and Prevention (CDC).


The move to revise the emergency authorization “avoids exposing patients to side effects, such as injection site reactions or allergic reactions, which can be potentially serious, from specific treatment agents that are not expected to provide benefit to patients who have been infected with or exposed to the omicron variant,” the FDA stated.

The move was recently recommended by the COVID-19 Treatment Guidelines Panel, part of the National Institutes of Health (NIH) on Dec. 23, 2021. At the time, the panel said the Omicron variant “is predicted to have markedly reduced susceptibility” to several COVID-19 monoclonal antibodies, “especially bamlanivimab plus etesevimab and casirivimab plus imdevimab.” Eli Lilly’s monoclonal antibody treatments offers bamlanivimab and etesevimab, and Regeneron offers casirivimab and imdevimab.

The panel added that GlakoSmithKline’s (GSK’s) and Vir Biotech’s antibody treatment, sotrovimab, “appears to retain activity against the Omicron variant.”

By Mimi Nguyen Ly

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