INDIANAPOLIS, April 12, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced changes to the purchase
agreements with the U.S. government for its neutralizing antibody
therapies authorized for emergency use as a treatment for COVID-19.
As part of Lilly's planned transition to only supply bamlanivimab
and etesevimab together, Lilly and the U.S. government have agreed
to modify the purchase agreement of bamlanivimab alone and focus on
supply of bamlanivimab and etesevimab together. Additionally, the
bamlanivimab and etesevimab agreement has been modified to enable
the supply of etesevimab to complement doses of bamlanivimab the
U.S. government already purchased, some of which have already
been delivered to sites of care. This terminates the purchase
agreement for bamlanivimab alone and cancels the remaining 350,856
doses that were scheduled to be delivered by the end of
March 2021.
Lilly's bamlanivimab was the first neutralizing monoclonal
antibody to receive emergency use authorization from the U.S. Food
and Drug Administration. Lilly subsequently developed bamlanivimab
and etesevimab for administration together, in order to meet the
potential challenge of SARS-CoV-2 variants likely to resist
treatment with either monoclonal antibody used alone.
Important Information about bamlanivimab alone and
bamlanivimab and etesevimab together
Bamlanivimab and
etesevimab together and bamlanivimab alone have not been approved
by the FDA for any use. It is not known if bamlanivimab and
etesevimab together or bamlanivimab alone are safe and
effective for the treatment of COVID-19.
Bamlanivimab and etesevimab together and bamlanivimab alone
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 bamlanivimab alone 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. Please see the FDA Letter of Authorization, Fact Sheet
for Healthcare Providers, and Fact Sheet for Patients, Parents and
Caregivers (English) (Spanish) for bamlanivimab alone.
Authorized Use and Important Safety
Information
Bamlanivimab and etesevimab together and
bamlanivimab alone 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 and bamlanivimab alone 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. Benefit of
treatment with bamlanivimab alone has not been observed 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 and bamlanivimab alone. Serious and unexpected adverse
events may occur that have not been previously reported with
bamlanivimab and etesevimab together and bamlanivimab alone.
Hypersensitivity Including Anaphylaxis and
Infusion-Related Reactions
Serious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of bamlanivimab and etesevimab together and
bamlanivimab alone. 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 and
bamlanivimab alone. 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. Benefit of treatment with bamlanivimab alone has
not been observed in patient 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
Bamlanivimab and etesevimab
together
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.
Bamlanivimab alone
Adverse events reported in at least
1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg
alone or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%),
dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and
vomiting (1% vs 3%).
Use in Specific
Populations
Pregnancy
There are
insufficient data on the use of bamlanivimab and etesevimab
together and bamlanivimab alone during pregnancy. Bamlanivimab and
etesevimab together and bamlanivimab alone 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
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 bamlanivimab (LY-CoV555) alone and bamlanivimab
and etesevimab (LY-CoV016) together as potential treatments for
patients with COVID-19, as well as etesevimab (LY-CoV016) alone and
the supply, distribution and contracts with the U.S. government
relating to these therapies, and reflects Lilly's current beliefs
and expectations. However, as with any such undertaking, there are
substantial risks and uncertainties in the process of drug
research, development and commercialization. Among other
things, there can be no guarantee that future study results
will be consistent with the results to date, that bamlanivimab
alone or bamlanivimab and etesevimab together will prove to be safe
and effective treatments or successful preventative therapies for
COVID-19, that bamlanivimab alone or bamlanivimab and etesevimab
together will receive regulatory approvals or additional
authorizations, that patients will volunteer to participate in
clinical trials or achieve positive outcomes, that Lilly will
obtain any additional purchase orders or supply contracts, or that
Lilly can provide an adequate supply of bamlanivimab, etesevimab or
both therapies together in all circumstances. For a further
discussion of these and other risks and uncertainties that could
cause actual results to differ from Lilly's expectations, please
see Lilly's most recent Forms 10-K and 10-Q filed with the U.S.
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.
Refer to:
|
Dani Barnhizer;
dbarnhizer@lilly.com; 317-607-6119 (Media)
|
|
Kevin Hern;
hern_kevin_r@lilly.com; 317-277-1838 (Investors)
|
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SOURCE Eli Lilly and Company