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January 28, 2022

FDA Restricts Use of Certain Monoclonal Antibodies Used to Treat COVID-19

In response to the growing prevalence of the omicron variant of SARS-CoV-2, FDA limited the authorization for use of bamlanivimab and etesevimab (administered together) and REGEN-COV (casirivimab and imdevimab) to individuals likely to have been infected with or exposed to variants susceptible to those treatments. An independent expert panel with the NIH COVID-19 Treatment Guidelines Panel had recommended against using these treatments due to their decreased efficacy against omicron and in light of recent data suggesting that omicron is responsible for greater than 99% of cases in the United States.

In its statement, the FDA also highlighted several other therapies, such as Paxlovid, sotrovimab, Veklury (remdesivir), and molnupiravir, which have greater expected efficacy against omicron than those therapies whose use the FDA limited. The FDA closed the statement by asserting that although these treatments are effective, they are “not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”