INDIANAPOLIS, May 4, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) is donating COVID-19 therapies to Direct
Relief, enabling the humanitarian organization to provide COVID-19
therapies at no cost to low- and lower-middle-income countries most
heavily impacted by the pandemic. This donation furthers both Lilly
and Direct Relief's charitable goal of providing access to COVID-19
treatments to patients in need by providing these medicines free of
charge to low- and lower-middle-income countries. Lilly will donate
both baricitinib (4 mg tablet) as well as bamlanivimab (LY-CoV555)
700 mg and etesevimab (LY-CoV016) 1400 mg together – providing
options to treat COVID-19 patients at different stages of the
disease.
Direct Relief will allocate donations of baricitinib to low- and
lower-middle-income countries (based on World Bank classification)
for the treatment of hospitalized COVID-19 patients requiring
supplemental oxygen, based on requests from these governments to
Direct Relief. Donations of bamlanivimab and etesevimab together
will be provided by Direct Relief to those countries for the
treatment of mild to moderate COVID-19 patients at high risk of
progressing to hospitalization or death in the outpatient
setting.
"Direct Relief is deeply grateful for Lilly's decision to make
its COVID-19 therapies available at no charge for people who
otherwise would not have access to them. This is a wonderful
example of each of us doing whatever we can to get through this
pandemic," said Direct Relief president and CEO Thomas Tighe. "Lilly's action provides both
important new options and potential resources for countries' health
and regulatory leaders to consider for the care of COVID-19
patients, and Direct Relief will of course move with urgency upon
receiving any such requests."
"Even as the world makes progress on vaccine roll-outs, it
remains vital for treatments to be available that can make a
meaningful difference for those fighting COVID-19," said
David A. Ricks, Lilly chairman and
CEO. "Both baricitinib as well as bamlanivimab with etesevimab
together have saved the lives of COVID-19 patients at different
stages of the disease. Bamlanivimab with etesevimab together
reduces the risk of hospitalizations and death for high-risk
patients in the outpatient setting, while recent data show
baricitinib in addition to current standard of care reduces death
in hospitalized patients."
The allocation of therapies will be based on the disease burden
and hospitalization rates in each country. This initiative, which
will commence immediately, subject to relevant local regulatory
requirements, currently goes through December 2021 and will be continuously assessed
based on the pandemic situation in these countries.
Ricks continued, "Today's announcement with Direct Relief will
help ensure access to Lilly's COVID-19 therapies for patients
around the world—no matter where they live."
The arrangement is part of Lilly's philanthropic efforts and
supports Lilly 30x30, the company's goal to improve access to
quality health care for 30 million people living in settings with
limited resources, each year, by 2030.
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.
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).
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
Click here for resources related to Lilly's COVID-19 efforts and
here for baricitinib's EUA.
About OLUMIANT ® (baricitinib)
OLUMIANT, a
once-daily, oral JAK inhibitor was discovered by Incyte and
licensed to Lilly. It is approved in the U.S. and more than 70
countries as a treatment for adults with moderate to severe
rheumatoid arthritis and was recently approved in the European
Union and Japan for the treatment
of adult patients with moderate to severe atopic dermatitis who are
candidates for systemic therapy. Olumiant was recently approved in
Japan for the treatment of
pneumonia associated with COVID-19 in hospitalized adult patients.
The U.S. FDA-approved labeling for Olumiant includes a Boxed
Warning for Serious Infections, Malignancy, and Thrombosis. See the
full Prescribing Information here. Baricitinib is also being
investigated in alopecia areata (AA), juvenile idiopathic arthritis
(JIA) and systematic lupus erythematosus (SLE).
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.
Important Information about bamlanivimab and etesevimab
together
Bamlanivimab and etesevimab together have not been
approved by the FDA for any use. It is not known if bamlanivimab
and etesevimab together are safe and effective for the
treatment of COVID-19.
Bamlanivimab and etesevimab together are authorized under
Emergency Use Authorization only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C §
360bbb-3(b)(1), unless the authorization is terminated or revoked
sooner.
Healthcare providers should review the Fact Sheet for
information on the authorized use of bamlanivimab and etesevimab
together and mandatory requirements of the EUA. Please see the FDA
Letter of Authorization, Fact Sheet for Healthcare Providers, and
Fact Sheet for Patients, Parents and Caregivers (English) (Spanish)
for bamlanivimab and etesevimab together.
Authorized Use and Important Safety
Information
Bamlanivimab and etesevimab together
are authorized for use under EUA for treatment of mild to
moderate COVID-19 in adults and pediatric patients (12 years of age
and older weighing at least 40 kg) with positive results of
direct SARS-CoV-2 viral testing, and who are at high risk for
progressing to severe COVID-19 and/or hospitalization.
Limitations of Authorized Use
- Bamlanivimab and etesevimab together are not authorized
for use in patients:
-
- who are hospitalized due to COVID-19, OR
- who require oxygen therapy due to COVID-19, OR
- who require an increase in baseline oxygen flow rate due to
COVID-19 in those on chronic oxygen therapy due to underlying
non-COVID-19 related comorbidity.
- Treatment with bamlanivimab and etesevimab together has
not been studied in patients hospitalized due to COVID-19.
Monoclonal antibodies, such as bamlanivimab and etesevimab,
may be associated with worse clinical outcomes when administered to
hospitalized patients with COVID-19 requiring high flow oxygen or
mechanical ventilation.
Important Safety Information
There are limited
clinical data available for bamlanivimab and etesevimab
together. Serious and unexpected adverse events may occur that have
not been previously reported with bamlanivimab and etesevimab
together.
Hypersensitivity Including Anaphylaxis and
Infusion-Related Reactions
Serious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of bamlanivimab with and without
etesevimab. If signs and symptoms of a clinically significant
hypersensitivity reaction or anaphylaxis occur, immediately
discontinue administration and initiate appropriate medications
and/or supportive care.
Infusion-related reactions have been observed with
administration of bamlanivimab and etesevimab together. These
reactions may be severe or life threatening. Signs and symptoms of
infusion-related reactions may include:
- fever, difficulty breathing, reduced oxygen saturation, chills,
fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia,
bradycardia), chest pain or discomfort, weakness, altered mental
status, nausea, headache, bronchospasm, hypotension, hypertension,
angioedema, throat irritation, rash including urticaria, pruritus,
myalgia, dizziness, and diaphoresis.
If an infusion-related reaction occurs, consider slowing or
stopping the infusion and administer appropriate medications and/or
supportive care.
Clinical Worsening After Bamlanivimab
Administration
Clinical worsening of COVID-19 after
administration of bamlanivimab has been reported and may include
signs or symptoms of fever, hypoxia or increased respiratory
difficulty, arrhythmia (e.g., atrial fibrillation, sinus
tachycardia, bradycardia), fatigue, and altered mental status. Some
of these events required hospitalization. It is not known if these
events were related to bamlanivimab use or were due to progression
of COVID-19.
Limitations of Benefit and Potential Risk in Patients with
Severe COVID-19
Treatment with bamlanivimab and
etesevimab together has not been studied in patients hospitalized
due to COVID-19. Monoclonal antibodies, such as
bamlanivimab and etesevimab, may be associated with worse
clinical outcomes when administered to hospitalized patients with
COVID-19 requiring high flow oxygen or mechanical ventilation. See
Limitations of Authorized Use.
Adverse Events
Based on Phase 2 data from
BLAZE-1, nausea was the most commonly reported adverse event,
reported by 4% of subjects in both bamlanivimab and etesevimab
together and placebo groups. Pruritus and pyrexia were more
frequently reported from subjects treated with both bamlanivimab
and etesevimab (2% and 1%) compared to placebo (1% and 0%,
respectively).
Based on Phase 3 data from BLAZE-1, the most common adverse
events were nausea, dizziness, and rash. These events each occurred
in 1% of subjects treated with bamlanivimab and etesevimab together
and in 1% of placebo subjects.
Use in Specific
Populations
Pregnancy
There are
insufficient data on the use of bamlanivimab and etesevimab
together during pregnancy. Bamlanivimab and etesevimab together
should only be used during pregnancy if the potential benefit
outweighs the potential risk for the mother and the fetus.
Breastfeeding
There are no available data on
the presence of bamlanivimab or etesevimab in human or animal
milk, the effects on the breastfed infant, or the effects on milk
production. Breastfeeding individuals with COVID-19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
About bamlanivimab
Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal
antibody (mAb) directed against the spike protein of SARS-CoV-2. It
is designed to block viral attachment and entry into human cells,
thus neutralizing the virus, potentially treating COVID-19.
Bamlanivimab emerged from the collaboration between Lilly and
AbCellera to create antibody therapies for the prevention and
treatment of COVID-19. Lilly scientists rapidly developed the
antibody in less than three months after it was discovered by
AbCellera and the scientists at the National Institute of Allergy
and Infectious Diseases (NIAID) Vaccine Research Center. It was
identified from a blood sample taken from one of the first U.S.
patients who recovered from COVID-19.
Lilly has successfully completed a Phase 1 study of
bamlanivimab in hospitalized patients with COVID-19
(NCT04411628). A Phase 2/3 study in people recently diagnosed
with COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) is
ongoing. Results from the Phase 2 cohorts of BLAZE-1 were published
in the New England Journal of Medicine and The Journal of
the American Medical Association. A Phase 3 study of
bamlanivimab alone or bamlanivimab and etesevimab together in
residents and staff at long-term care facilities (BLAZE-2,
NCT04497987) is also ongoing. In addition, bamlanivimab is being
tested in the National Institutes of Health-led ACTIV-2 study in
ambulatory COVID-19 patients.
About etesevimab
Etesevimab (LY-CoV016, also known as
JS016) is a recombinant fully human monoclonal neutralizing
antibody, which specifically binds to the SARS-CoV-2 surface spike
protein receptor binding domain with high affinity and can block
the binding of the virus to the ACE2 host cell surface receptor.
Point mutations were introduced into the native human IgG1 antibody
to mitigate effector function. Lilly licensed etesevimab from
Junshi Biosciences after it was jointly developed by Junshi
Biosciences and the Institute of Microbiology, Chinese Academy of
Science (IMCAS). Junshi Biosciences leads development
in Greater China, while Lilly leads development in the rest of
the world.
Lilly has successfully completed a Phase 1 study (NCT04441931)
of etesevimab in healthy U.S. volunteers to evaluate the safety,
tolerability, pharmacokinetics and immunogenicity. A Phase 2/3
study in people recently diagnosed with COVID-19 in the ambulatory
setting (BLAZE-1, NCT04427501) is ongoing. Results from the Phase 2
cohorts of BLAZE-1 were published in the New England Journal of
Medicine and The Journal of the American Medical
Association. Junshi Biosciences has completed a similar
Phase 1 study in healthy volunteers in China and has initiated Phase 1b/2 trials in COVID-19 patients globally.
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
being studied to understand their potential in treating
complications of COVID-19, and the company is collaborating with
partner companies to discover and develop novel antibody treatments
for COVID-19. Click here for resources related to Lilly's
COVID-19 efforts.
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 www.lilly.com and www.lilly.com/news. P-LLY
About Lilly 30x30
Through investments in people,
medicines and health systems, we aim to improve access to quality
health care for 30 million people living in limited resource
settings annually by 2030. We call this global effort Lilly
30x30. To achieve our goal, we have structured Lilly 30x30 as a
company-wide effort in strategic collaboration with valued external
partners. Lilly 30x30 initiatives include activities across three
areas of impact: pipeline, programs and partnerships. In each of
these areas, we are leading cross-functional teams to develop
high-impact, scalable projects and solutions.
About Direct Relief
Direct Relief is active in all 50
states and U.S. territories, with a mission to improve the health
and lives of people affected by poverty or emergencies – without
regard to politics, religion, or ability to pay. Direct Relief now
supports more than 1,500 nonprofit community health centers, free
and charitable clinics, public health departments, and other
safety-net organizations through the U.S., who in turn operate more
than 5,000 clinical sites and provide care to millions of
people.
Lilly 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),
bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together as
potential treatments for patients with COVID-19 and reflects
Lilly's current beliefs and expectations. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of research, development and
commercialization. Among other things, there can be no guarantee
that planned or ongoing studies will be completed as planned, that
future study results will be consistent with the results to date,
that either OLUMIANT or bamlanivimab (LY-CoV555) and etesevimab
(LY-CoV016) together will receive additional regulatory approvals
or authorizations or be commercially successful, or that OLUMIANT
or bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) together
will prove to be safe and effective treatments or successful
preventative therapies for COVID-19. For further discussion of
these and other risks and uncertainties, see Lilly'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 undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
Refer to:
|
Dani Barnhizer;
dbarnhizer@lilly.com; 317-607-6119 (Media)
|
|
Kristen Basu;
basu_kristen_porter@lilly.com; 317-447-2199 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838
(Investors)
|
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SOURCE Eli Lilly and Company