November 21, 2020
"Since the start of the COVID-19 pandemic, Lilly has been committed
to finding potential treatments to help people around the world who've
been impacted by this virus," said David A. Ricks, Lilly chairman and
CEO. "Today's FDA action for baricitinib marks the second Lilly therapy
to be granted an EUA, in addition to the recent neutralizing antibody
EUA for high-risk non-hospitalized patients, increasing the number of
treatment options for COVID-19 patients at different stages of the disease.
This is an important milestone for hospitalized patients on oxygen, as
baricitinib may help speed their recovery."
The FDA grants emergency use authorization to provide availability of
a medicine that may help diagnose, treat or prevent a life-threatening
disease when no adequate and approved alternatives are available.
This use of baricitinib is authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use, unless the authorization is terminated or
revoked sooner. The authorization is temporary and does not replace
the formal review and approval process. In the US, baricitinib has
not been approved by the FDA to treat COVID-19, and the efficacy,
safety and optimal duration of treatment of baricitinib for COVID-19
has not been established. This is the first combination regimen
authorized by FDA. Evaluation of baricitinib's efficacy and safety
as a treatment for COVID-19 is ongoing in clinical trials.
The EUA is based on data from the Adaptive COVID-19 Treatment Trial
(ACTT-2), a randomized double-blind, placebo-controlled study to
evaluate the efficacy and safety of baricitinib in combination with
remdesivir versus placebo with remdesivir in hospitalized patients
with or without oxygen requirements conducted by the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH). All patients received standard supportive
care by the trial site hospital. The recommended dose for this EUA is
baricitinib 4-mg once daily for 14 days or until hospital