|
 It
lowered the dose to 1,200 mg and allowed the administration of
casirivimab and imdevimab by injecting under the skin when
intravenous infusion is not possible and would lead to a delay in
treatment, the drugmaker said.
The drugmaker had been working on a lower dose of REGEN-COV that can
be given subcutaneously as logistical challenges associated with
intravenous infusion had led to lackluster demand for antibody
drugs.
The US Food and Drug Administration (FDA) had in November authorized
a 2,400 mg total dose, administered as a single dose directly
injected to a vein for non-hospitalized COVID-19 patients.
The therapy belongs to a class of drugs called monoclonal
antibodies, which mimic natural antibodies the body produces to
fight off the infection.
The FDA had allowed the emergency use of a similar treatment
developed by Eli Lilly and Co in February, while an antibody drug
developed by Vir Biotechnology Inc along with GlaxoSmithKline PLC
was granted authorization late last month.
Regeneron said it expects to submit an application for full approval
of REGEN-COV in non-hospitalized outpatients with COVID-19 later
this summer.
[to top of second column] |
The drugmaker expects to
deliver at least 1 million doses of the therapy
to the U.S. government in the second quarter and
said the government may accept additional doses
of up to 1.25 million doses through September.
Regeneron is also developing the cocktail as a
preventive medicine and has reported positive
data from its clinical studies that showed it
protected household contacts from exposure to
the coronavirus and reduced the risk of
progressing to symptomatic COVID-19.
(Reporting by Manojna Maddipatla and Amruta
Khandekar in Bengaluru; Editing by Arun Koyyur)
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