INDIANAPOLIS, Dec. 11, 2020 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced today that
The New England Journal of Medicine has
published peer-reviewed results 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). The Phase 3 study included 1,033
patients from 67 trial sites in eight countries. These results
support the emergency use authorization (EUA) issued by the U.S.
Food and Drug Administration (FDA) on Nov.
19 for baricitinib in combination with remdesivir in
hospitalized patients with COVID-19 requiring supplemental
oxygen.
"These published data from a rigorous, double-blind,
placebo-controlled trial are critical in helping the scientific
community make better-informed treatment decisions to improve
clinical outcomes for patients," said Andre
Kalil, M.D., professor at the University of Nebraska Medical Center, a principal
investigator of the ACTT studies and lead study author of the
ACTT-2 New England Journal of Medicine manuscript. "Results
of this study demonstrated baricitinib in combination with
remdesivir provided a faster median recovery time and reduced
progression to ventilation or death compared to remdesivir alone in
hospitalized COVID-19 patients on oxygen."
"Presently, there are limited published placebo-controlled data
assessing treatment options to manage the symptoms and progression
of COVID-19," said Anabela Cardoso,
M.D., an author of the New England Journal of Medicine paper
and Lilly global brand development lead, immunology. "We need
high-quality research such as the ACTT-2 study to evaluate
therapies to fight this pandemic and are pleased that this
medicine is now available for patients under EUA."
Read the full NIAID press release on ACTT-2 results here.
Baricitinib, an oral JAK inhibitor, was discovered by
Incyte and licensed to Lilly. Please see below for important
warnings and information about the authorized use
of baricitinib in the U.S. In the
U.S., 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.
For information on the authorized use of baricitinib and
mandatory requirements under the EUA, please review the FDA
Letter of Authorization, Fact Sheet for Healthcare
Providers and Fact Sheet for Patients, Parents and Caregivers
(English; Spanish).
Authorized Use Under the EUA and Important Safety Information
for baricitinib (in the United
States) for COVID-19
Baricitinib is authorized for use under an Emergency Use
Authorization (EUA) in combination with remdesivir, for treatment
of suspected or laboratory confirmed coronavirus disease 2019
(COVID-19) in hospitalized adults and pediatric patients 2 years of
age or older, requiring supplemental oxygen, invasive mechanical
ventilation, or extracorporeal membrane oxygenation
(ECMO).
Baricitinib has not been approved for the treatment of
COVID-19, but has been authorized for emergency use by the
FDA. Baricitinib is authorized under an EUA only for the duration
of the declaration that circumstances exist justifying the
authorization of the EUA of baricitinib under Section 564(b)(1) of
the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is
terminated or revoked sooner.
Important Safety Information about baricitinib for
COVID-19
The following provides essential safety information on the
unapproved use of baricitinib under the Emergency Use
Authorization.
Warnings
Serious Infections: Serious infections have occurred in
patients receiving baricitinib. Avoid the use of baricitinib with
known active tuberculosis. Consider if the potential benefits
outweigh the potential risks of baricitinib treatment in patients
with active serious infections other than COVID-19 or
chronic/recurrent infections.
Thrombosis: In hospitalized patients with COVID-19,
prophylaxis for venous thromboembolism is recommended unless
contraindicated. If clinical features of deep vein thrombosis or
pulmonary embolism occur, patients should be evaluated promptly and
treated appropriately.
Abnormal Laboratory Values: Evaluate at baseline and
thereafter according to local patient management practice. Monitor
closely when treating patients with abnormal baseline and
post-baseline laboratory values. Follow dose adjustments as
recommended in the Fact Sheet for Healthcare Providers for patients
with abnormal renal, hematological and hepatic laboratory
values. Manage patients according to routine clinical
guidelines.
Hypersensitivity: If a serious hypersensitivity
occurs, discontinue baricitinib while evaluating the potential
causes of the reaction.
See Warnings and Precautions in the FDA-approved full
Prescribing Information for additional information on risks
associated with longer-term treatment with baricitinib.
Serious Side Effects: Serious venous thrombosis,
including pulmonary embolism, and serious infections have been
observed in COVID-19 patients treated with baricitinib and are
known adverse drug reactions of baricitinib.
There are limited clinical data available for baricitinib use in
coronavirus 2019 (COVID-19). Additional information regarding
baricitinib for its FDA-approved indication, including safety
information, may be found in the full Prescribing Information,
including Boxed Warning about Serious Infections, Malignancies, and
Thrombosis, and Medication Guide.
Use in Specific Populations
Pregnancy: Baricitinib should be used during pregnancy
only if the potential benefit justifies the potential risk for the
mother and the fetus.
Renal Impairment: There are limited data for baricitinib
in patients with severe renal impairment. Baricitinib is
not recommended for patients who are on dialysis, have end-stage
renal disease, or have acute kidney injury.
Hepatic Impairment: Baricitinib has not been studied in
patients with severe hepatic impairment. Baricitinib should only be
used in patients with severe hepatic impairment if the potential
benefit outweighs the potential risk.
BC HCP EUA ISI 19NOV2020
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 is
testing both single antibody therapy as well as combinations of
antibodies as potential therapeutics for COVID-19.
Click here for resources related to Lilly's COVID-19
efforts and here for baricitinib's EUA.
About baciritinib (OLUMIANT ®)
OLUMIANT is a once-daily, oral JAK inhibitor approved in the
U.S. and more than 70 countries as a treatment for adults with
moderate to severe rheumatoid arthritis (RA) and was recently
approved in the European Union for the treatment of adult patients
with moderate to severe atopic dermatitis who are candidates for
systemic therapy. The U.S. FDA-approved labeling for Olumiant
includes a Boxed Warning for Serious Infections, Malignancy, and
Thrombosis. See the full Prescribing Information here.
In December 2009, Lilly and Incyte
announced an exclusive worldwide license and collaboration
agreement for the development and commercialization of baricitinib
and certain follow-on compounds for patients with inflammatory and
autoimmune diseases.
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with
discovery to create medicines that make life better for people
around the world. We were founded more than a century ago by a man
committed to creating high-quality medicines that meet real needs,
and today we remain true to that mission in all our work. Across
the globe, Lilly employees work to discover and bring life-changing
medicines to those who need them, improve the understanding and
management of disease, and give back to communities through
philanthropy and volunteerism. To learn more about Lilly, please
visit us at lilly.com and lilly.com/newsroom. P-LLY
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.
Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements (as
that term is defined in the Private Securities Litigation Reform
Act of 1995) about OLUMIANT (baricitinib) as a potential treatment
for patients with COVID-19 and as a treatment for patients with
rheumatoid arthritis and other conditions, as well as its supply,
and reflects Lilly's and Incyte's current beliefs and expectations.
However, as with any such undertaking there are substantial risks
and uncertainties in the process of drug development and
commercialization. Among other things, there can be no guarantee
that OLUMIANT will receive additional regulatory approvals or
authorizations or be commercially successful, that we can provide
an adequate supply of OLUMIANT in all circumstances, or that
OLUMIANT will be safe and effective as a treatment for COVID-19.
For further discussion of these and other risks and uncertainties,
see Lilly's and Incyte's most recent respective Form 10-K and Form
10-Q filings with the United States Securities and Exchange
Commission. Except as required by law, Lilly and Incyte undertake
no duty to update forward-looking statements to reflect events
after the date of this release.
Refer to:
|
Kristen Basu;
basu_kristen_porter@lilly.com; +1-317-447-2199 (Lilly
media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; +1-317-277-1838 (Lilly
investors)
|
|
Catalina Loveman;
cloveman@incyte.com; +1-302-498-6171 (Incyte media)
|
|
Michael Booth, DPhil;
mbooth@incyte.com; +1-302-498-5914 (Incyte investors)
|
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SOURCE Eli Lilly and Company