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For managing patients with mild to moderate COVID-19, casirivimab and imdevimab co-therapy has been granted emergency use authorization (EUA) by US-FDA.
On 21 Nov 2020, the United States Food and Drug Administration (US-FDA) has given a EUA for casirivimab and imdevimab to be given together for treating mild to moderate COVID-19.
It has been advocated for adults and pediatrics (age: 12 years or more, weight: at least 40 kgs/about 88 pounds) having positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing and who are at elevated risk for advancing to severe COVID-19 infection. This includes patients aged 65 years or more or who have specific chronic illnesses.
Casirivimab and
imdevimab given together were found to minimize COVID-19-associated
hospitalization or emergency room visits in patients at elevated risk
for disease advancement within 28 days after therapy in comparison
with placebo.
Both the antibodies
are particularly directed against the spike protein of SARS-CoV-2 and
are designed to impede the attachment of the virus and its entrance
into the human cells. The EUA was issued based on the data from a
randomized, double-blind, placebo-controlled trial in 799
non-hospitalized adult patients suffering from mild to moderate
COVID-19 symptoms.
Of these
participants, 266 subjects were given a single intravenous infusion
of 2400 mg casirivimab and imdevimab (1200 mg of each), 267 subjects
were given 8000 mg casirivimab and imdevimab (4000 mg of each), and
266 subjects were given a placebo, within 3 days of getting a
positive SARS-CoV-2 viral test. The time-weighted mean alteration in
viral load from baseline was the primary outcome parameter.
On the 7th day, the
viral load reduction was found to be greater in patients given
casirivimab and imdevimab compared to patients given a placebo. The
most vital efficacy proof of this combo was illustrated from the
secondary outcome of medically attended visits linked to coronavirus,
specifically emergency room visits and hospitalizations within 28
days after therapy.
For individuals at
elevated risk for disease advancement, hospitalizations and emergency
room visits were found to occur in 3% of patients receiving
casirivimab and imdevimab in comparison with 9% in individuals
receiving placebo. The impact on viral load, minimization in
hospitalizations, and emergency room visits were found to be
comparable in patients administered with either of the two doses.
The possible
treatment-emergent adverse effects include flushing, anaphylaxis,
infusion-associated reactions, chills, hives, itching, and fever. The
efficacy and safety of this investigational COVID-19 therapeutic
approach continue to be assessed. Both these antibodies must be given
together by intravenous infusion and this combination is not
authorized for individuals who are hospitalized or need oxygen due to
COVID-19 infection.
The recommended dilution instructions for casirivimab and imdevimab
for intravenous infusion is depicted in the following table:
A benefit of the combination of casirivimab and imdevimab has not been demonstrated in hospitalized COVID-19 patients. These antibodies may be linked with worse clinical outcomes when given to hospitalized COVID-19 individuals needing mechanical ventilation or high flow oxygen supplementation.
The EUA of these
antibodies yields health care providers another potential tool to
tackle the pandemic. Authorizing these monoclonal antibodies may aid
outpatients to prevent hospitalization and minimize the overburden on
the medical care system.
US-FDA
Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19
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