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FDA Revises Authorizations For COVID-19 Monoclonal Antibody Treatments

fda july23 27jan22 lt

The U.S. Food and Drug Administration has revised the authorizations for two monoclonal antibody treatments - bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) - to limit their use to only when the patient is likely to have been infected with or exposed to a variant that is susceptible to these treatments.

The action was taken by the FDA based on the most recent information and data available on treatment for the fast spreading coronavirus omicron variant. As per the data, these two treatments are highly unlikely to be active against the omicron variant, which is circulating at a very high frequency throughout the U.S.

The FDA noted that these two monoclonal antibody treatments are not authorized for use in any U.S. states, territories, and jurisdictions at this time. It added that use of these treatments may be authorized in these regions again, if in future patients are infected or exposed to a variant that is susceptible to these treatments.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens such as viruses, like SARS-CoV-2. The virus can mutate over time, resulting in certain treatments not working against certain variants such as omicron in this case.

The omicron variant of SARS-CoV-2 is estimated to currently account for more than 99 percent of cases in the U.S. as of January 15, based on Centers for Disease Control and Prevention data. Therefore, these treatments are not authorized to be used at this time.

The FDA noted that this will avoid 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 NIH COVID-19 Treatment Guidelines Panel, an independent panel of national experts, recently recommended against the use of these two monoclonal antibody treatments because of markedly reduced activity against the omicron variant.

Meanwhile, the FDA added that there are several other therapies like Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir that are expected to work against the omicron variant. They are already authorized or approved to treat patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death.

However, the FDA warned that the authorized treatments are not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.

Data has clearly demonstrated that the available, safe and effective vaccines can lower the risk of developing COVID-19 and experiencing the potential associated serious disease progression, including hospitalization and death.

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