SILVER SPRING, Md.,
Jan. 24, 2022 /PRNewswire/ -- 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.
Media Contact: Chanapa Tantibanchachai,
202-384-2219
Consumer Inquiries: Email, 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, products that give off electronic radiation, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration