FDA Restricts Use of 2 Monoclonal Antibody Therapies Due to Omicron Variant

The Food and Drug Administration (FDA) has revised the authorizations for bamlanivimab plus etesevimab and REGEN-COV (casirivimab and imdevimab) to limit the use of these monoclonal antibodies only to patients who are likely infected with or exposed to variants susceptible to these treatments.

According to recent data, these treatments were found to be “highly unlikely to be active against the Omicron variant, which is circulating at a very high frequency throughout the United States.” As a result, these treatments are not authorized for use in any US states, territories, and jurisdictions at this time.

As of January 15, the Omicron variant was found to account for more than 99% of cases in the US based on data from the Centers for Disease Control and Prevention (CDC). The FDA stated that restricting the use of these monoclonal antibody treatments will avoid exposing patients to drugs that are not expected to provide benefit, as well as to unnecessary side effects, such as injection site reactions or allergic reactions.

The National Institutes of Health (NIH) COVID-19 Treatment Guidelines Panel recently recommended against the use of bamlanivimab plus etesevimab and REGEN-COV (casirivimab and imdevimab) due to “markedly reduced activity against the Omicron variant and because real-time testing to identify rare, non-Omicron variants is not routinely available.” 


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In a statement, the FDA noted that alternative therapies such as molnupiravir, Paxlovid, remdesivir, and sotrovimab are expected to work against the Omicron variant. These treatments are 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.

Reference

Coronavirus (COVID-19) update: FDA limits use of certain monoclonal antibodies to treat COVID-19 due to the omicron variant. News release. US Food and Drug Administration. January 24, 2022. Accessed January 25, 2022. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-limits-use-of-certain-monoclonal-antibodies-to-treat-covid-19-due-to-the-omicron-variant-301466918.html

Source: Medical Bag https://www.medicalbag.com/home/news/fda-restricts-use-of-2-monoclonal-antibody-therapies-due-to-omicron-variant/

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