Baricitinib in Combination with Remdesivir Reduces Time to Recovery in Hospitalized Patients with COVID-19 in NIAID-Sponsored...
On Monday, September 14th, Eli Lilly and Company and Incyte
announced initial data emerging from the Adaptive COVID-19
Treatment Trial (ACTT-2) sponsored by the National Institute of
Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH). ACTT-2 included more than 1,000
patients and began on May 8 to assess the efficacy and safety of a
4-mg dose of baricitinib plus remdesivir versus remdesivir in
hospitalized patients with COVID-19.
Baricitinib in combination with remdesivir met
the primary endpoint of reduction of time to recovery in comparison
Study investigators noted an approximately
one-day reduction in median recovery time for the overall patient
population treated with baricitinib in combination with remdesivir
versus those treated with remdesivir. This finding was
statistically significant. Recovery was defined as the participant
being well enough for hospital discharge, meaning the participant
either no longer required supplemental oxygen or ongoing medical
care in the hospital, or was no longer hospitalized at Day 29. The
study also met a key secondary endpoint comparing patient outcomes
at Day 15 using an ordinal 8-point scale ranging from fully
recovered to death.
An independent data and safety monitoring board
overseeing the double-blind, randomized controlled trial met
regularly throughout the trial to review safety data. Additional
analyses are ongoing to understand other clinical outcome data,
including mortality and safety data. NIAID is expected to publish
full details of the study in a peer-reviewed journal.
“As a tightly knit organization, we are truly
working as one team to help discover a number of treatment options
for COVID-19, including the potential role of baricitinib. We are
pleased by the topline ACTT-2 results and look forward to the full
data to completely understand baricitinib’s impact on COVID-19,”
says Dr. Doron Sagman, Vice President, R&D and Medical Affairs,
Eli Lilly Canada.
Based on the ACTT-2 data, Lilly plans to discuss
the potential for emergency use authorization (EUA) with the U.S.
Food and Drug Administration (FDA) and to explore similar measures
with other regulatory agencies, including Health Canada, for
baricitinib as a treatment of hospitalized patients with COVID-19.
If authorized for use in Canada, Lilly will propose that
baricitinib be available through commercial channels and will work
with hospitals and governments to ensure patient access. Lilly will
continue to create adequate supply for rheumatoid arthritis (RA)
patients and ensure baricitinib remains available in Canada and
around the world where it is approved. In Canada, baricitinib is
approved for RA patients at a 2-mg daily dose.
Lilly will review the ACTT-2 data with NIAID and
assess any impact on COV-BARRIER, the Phase 3 randomized,
double-blind, placebo-controlled study it initiated in June to
evaluate the efficacy and safety of baricitinib versus background
therapy in hospitalized adults with COVID-19 in the U.S., Europe,
Asia and Latin America.
Lilly is also currently supporting ongoing
multisite and single-site investigator-initiated trials in Europe
and North America, including the SAIL-004 study in Nova Scotia,
Canada, in hospitalized patients with COVID-19 infections.
About Lilly’s COVID-19 Efforts
Lilly is bringing the full force of its scientific and medical
expertise to attack the coronavirus pandemic around the world.
Existing Lilly medicines are now being studied to understand their
potential in treating complications of COVID-19, and the company is
collaborating with two partner companies to discover novel antibody
treatments for COVID-19. Lilly intends to test both single antibody
therapy as well as combinations of antibodies (sometimes known as
antibody cocktails) as potential therapeutics for COVID-19.
About OLUMIANT®In Canada,
OLUMIANT (baricitinib), in combination with methotrexate (MTX), is
indicated for reducing the signs and symptoms of moderate- to
severe rheumatoid arthritis (RA) in adult patients who have
responded inadequately to one or more disease-modifying
anti-rheumatic drugs (DMARDs). OLUMIANT can be used as a
monotherapy in cases of intolerance to MTX.1
OLUMIANT is believed to interfere with the
activity of an enzyme called Janus Kinase (JAK). Normally JAK
enzymes help turn on your immune system when you need it. The
immune system then causes swelling and tenderness. This is called
inflammation. There are four known JAK enzymes: JAK1, JAK2, JAK3
and TYK2. JAK-dependent cytokines have been implicated in the
pathogenesis of a number of inflammatory and autoimmune diseases.2
OLUMIANT has greater inhibitory potency at JAK1, JAK2 and TYK2
relative to JAK3; however, the relevance of inhibition of specific
JAK enzymes to therapeutic effectiveness is not currently
CanadaEli Lilly and Company is a global
healthcare leader that unites caring with discovery to make life
better for people around the world. We were founded more than a
century ago by Colonel Eli Lilly, who was committed to creating
high quality medicines that meet people’s needs, and today we
remain true to that mission in all our work. Lilly employees work
to discover and bring life-changing medicines to people who need
them, improve the understanding and management of disease, and
contribute to our communities through philanthropy and
Eli Lilly Canada was established in 1938, the
result of a research collaboration with scientists at the
University of Toronto, which eventually produced the world’s first
commercially available insulin. Our work focuses on oncology,
diabetes, autoimmunity, neurodegeneration, and pain. To learn more
about Lilly Canada, please visit us at www.lilly.ca.
About Incyte Incyte is a
Wilmington, Delaware-based, global biopharmaceutical company
focused on finding solutions for serious unmet medical needs
through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
For our perspective on issues in healthcare and
innovation, follow us on twitter @LillyPadCA and
Media Contact: Samira
References1 OLUMIANT Product Monograph2 Walker
JG and Smith MD. J Rheumatol. 2005;32;1650-1653.
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