SILVER SPRING, Md.,
Nov. 21, 2020 /PRNewswire/
-- Today, the U.S. Food and Drug Administration issued an
emergency use authorization (EUA) for casirivimab and imdevimab to
be administered together for the treatment of mild to moderate
COVID-19 in adults and pediatric patients (12 years of age or older
weighing at least 40 kilograms [about 88 pounds]) with
positive results of direct SARS-CoV-2 viral testing and who are at
high risk for progressing to severe COVID-19. This includes those
who are 65 years of age or older or who have certain chronic
medical conditions.
In a clinical trial of patients with COVID-19, casirivimab and
imdevimab, administered together, were shown to reduce
COVID-19-related hospitalization or emergency room visits in
patients at high risk for disease progression within 28 days after
treatment when compared to placebo. The safety and effectiveness of
this investigational therapy for use in the treatment of COVID-19
continues to be evaluated.
Casirivimab and imdevimab must be administered together by
intravenous (IV) infusion.
Casirivimab and imdevimab are not authorized for patients who
are hospitalized due to COVID-19 or require oxygen therapy due to
COVID-19. A benefit of casirivimab and imdevimab treatment has not
been shown in patients hospitalized due to COVID-19. Monoclonal
antibodies, such as casirivimab and imdevimab, may be associated
with worse clinical outcomes when administered to hospitalized
patients with COVID-19 requiring high flow oxygen or mechanical
ventilation.
"The FDA remains committed to advancing the nation's public
health during this unprecedented pandemic. Authorizing these
monoclonal antibody therapies may help outpatients avoid
hospitalization and alleviate the burden on our health care
system," said FDA Commissioner Stephen M.
Hahn, M.D. "As part of our Coronavirus Treatment
Acceleration Program, the FDA uses every possible pathway to make
new treatments available to patients as quickly as possible while
continuing to study the safety and effectiveness of these
treatments."
Monoclonal antibodies are laboratory-made proteins that mimic
the immune system's ability to fight off harmful pathogens such as
viruses. Casirivimab and imdevimab are monoclonal antibodies that
are specifically directed against the spike protein of SARS-CoV-2,
designed to block the virus' attachment and entry into human
cells.
"The emergency authorization of these monoclonal antibodies
administered together offers health care providers another tool in
combating the pandemic," said Patrizia
Cavazzoni, M.D., acting director of the FDA's Center for
Drug Evaluation and Research. "We will continue to facilitate the
development, evaluation and availability of COVID-19
therapies."
The issuance of an EUA is different than an FDA approval. In
determining whether to issue an EUA, the FDA evaluates the totality
of available scientific evidence and carefully balances any known
or potential risks with any known or potential benefits of the
product for use during an emergency. Based on the FDA's review of
the totality of the scientific evidence available, the agency has
determined that it is reasonable to believe that casirivimab and
imdevimab administered together may be effective in treating
patients with mild or moderate COVID-19. When used to treat
COVID-19 for the authorized population, the known and potential
benefits of these antibodies outweigh the known and potential
risks. There are no adequate, approved and available alternative
treatments to casirivimab and imdevimab administered together for
the authorized population.
The data supporting this EUA for casirivimab and imdevimab are
based on a randomized, double-blind, placebo-controlled clinical
trial in 799 non-hospitalized adults with mild to moderate COVID-19
symptoms. Of these patients, 266 received a single intravenous
infusion of 2,400 milligrams casirivimab and imdevimab (1,200 mg of
each), 267 received 8,000 mg casirivimab and imdevimab (4,000 mg of
each), and 266 received a placebo, within three days of obtaining a
positive SARS-CoV-2 viral test.
The prespecified primary endpoint for the trial was
time-weighted average change in viral load from baseline. Viral
load reduction in patients treated with casirivimab and imdevimab
was larger than in patients treated with placebo at day seven.
However, the most important evidence that casirivimab and imdevimab
administered together may be effective came from the predefined
secondary endpoint of medically attended visits related to
COVID-19, particularly hospitalizations and emergency room visits
within 28 days after treatment. For patients at high risk for
disease progression, hospitalizations and emergency room visits
occurred in 3% of casirivimab and imdevimab-treated patients on
average compared to 9% in placebo-treated patients. The effects on
viral load, reduction in hospitalizations and ER visits were
similar in patients receiving either of the two casirivimab and
imdevimab doses.
Under the EUA, fact sheets that provide important information
about using casirivimab and imdevimab administered together in
treating COVID-19 as authorized must be made available
to health care providers and to patients and
caregivers. These fact sheets include dosing instructions,
potential side effects and drug interactions. Possible side effects
of casirivimab and imdevimab include: anaphylaxis and
infusion-related reactions, fever, chills, hives, itching and
flushing.
The EUA was issued to Regeneron Pharmaceuticals Inc.
Additional Resources:
- Casirivimab and Imdevimab EUA Letter of Authorization
- Frequently Asked Questions on the Emergency Use Authorization
for Casirivimab and Imdevimab
- Emergency Use Authorization: Therapeutics
- Coronavirus Disease (COVID-19)
Media Contact: Chanapa Tantibanchachai, 202-384-2219
Consumer Inquiries: Email or 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.
View original content to download
multimedia:http://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-for-treatment-of-covid-19-301178466.html
SOURCE U.S. Food and Drug Administration