Lilly, Incyte Get Emergency Use Authorization for Covid-19 Treatment as Monotherapy
July 29 2021 - 10:16AM
Dow Jones News
By Chris Wack
Eli Lilly & Co. and Incyte Corp. said the U.S. Food and Drug
Administration has broadened the emergency use authorization for
baricitinib to allow for treatment with or without remdesivir,
whereas the EUA was previously restricted to use only in
combination with remdesivir.
The authorization now provides for the use of baricitinib for
treatment of Covid-19 in hospitalized adults and pediatric patients
two years of age or older requiring supplemental oxygen,
non-invasive or invasive mechanical ventilation or extracorporeal
membrane oxygenation.
The companies said the FDA based its decision on data from a
Phase 3 study, a randomized, placebo-controlled study of
hospitalized patients comparing baricitinib 4 mg once daily plus
standard of care versus placebo plus standard of care.
While the composite primary endpoint of the study, which was
defined as a difference in the estimated proportion of participants
progressing to non-invasive ventilation including high flow oxygen
or invasive mechanical ventilation or death by day 28, didn't meet
statistical significance, baricitinib-treated patients were less
likely than those receiving standard of care to progress to
ventilation or death.
A pre-specified key secondary endpoint showed baricitinib, in
addition to standard of care, meaningfully reduced the risk of
death by 39% by day 28. No new safety signals potentially related
to the use of baricitinib were identified.
Under the emergency use authorization, inpatient pharmacies in
the U.S. may order 1-mg and 2-mg tablets of baricitinib through
Lilly's authorized distributors.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
July 29, 2021 10:04 ET (14:04 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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