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 3. FDA Newsroom
 4. Press Announcements
 5. Coronavirus (COVID-19) Update: FDA Limits Use of Certain Monoclonal
    Antibodies to Treat COVID-19 Due to the Omicron Variant

 1. Press Announcements

FDA Statement


CORONAVIRUS (COVID-19) UPDATE: FDA LIMITS USE OF CERTAIN MONOCLONAL ANTIBODIES
TO TREAT COVID-19 DUE TO THE OMICRON VARIANT


THE FOLLOWING IS ATTRIBUTED TO PATRIZIA CAVAZZONI, M.D., DIRECTOR OF THE FDA’S
CENTER FOR DRUG EVALUATION AND RESEARCH

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For Immediate Release: January 24, 2022 Statement From: Patrizia Cavazzoni, M.D.
Director - Center for Drug Evaluation and Research





Español

As we have throughout the COVID-19 pandemic, the U.S. Food and Drug
Administration has used the best available science as the virus has evolved to
make informed decisions with the health and safety of the American public in
mind. Ensuring that healthcare providers on the frontlines have the best tools
available to treat patients is a top priority for the agency. 

In light of the most recent information and data available, today, the FDA
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. 

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. 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.  

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. And like other infectious organisms, SARS-CoV-2 can mutate over
time, resulting in certain treatments not working against certain variants such
as omicron. This is the case with these two treatments for which we’re making
changes today. 

Based on Centers for Disease Control and Prevention data, the omicron variant of
SARS-CoV-2 is estimated to account for more than 99% of cases in the United
States as of Jan. 15. Therefore, it’s highly unlikely that COVID-19 patients
seeking care in the U.S. at this time are infected with a variant other than
omicron, and these treatments are not authorized to be used at this time. This
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 NIH COVID-19 Treatment Guidelines Panel, an independent panel of national
experts, recently recommended against the use of bamlanivimab and etesevimab
(administered together) and REGEN-COV (casirivimab and imdevimab) because of
markedly reduced activity against the omicron variant and because real-time
testing to identify rare, non-omicron variants is not routinely available.  

Importantly, there are several other therapies – Paxlovid, sotrovimab, Veklury
(remdesivir), and molnupiravir – that are expected to work against the omicron
variant, and that 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. Healthcare providers should consult
the NIH panel’s COVID-19 treatment guidelines and assess whether these
treatments are right for their patients.

While it’s critical that we have ways to treat those who contract COVID-19, 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 your risk
of developing COVID-19 and experiencing the potential associated serious disease
progression, including hospitalization and death.

The FDA is committed to continuing to review emerging data on all COVID-19
therapies related to the potential impact of variants and revise the
authorizations further as appropriate to ensure healthcare providers have an
effective arsenal of treatments for patients.

###

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   01/24/2022


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