INDIANAPOLIS, Nov. 2, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) today announced an additional purchase by
the U.S. government for bamlanivimab with etesevimab for
administration together. This neutralizing antibody therapy is
authorized for emergency use for the treatment of mild to moderate
COVID-19 or for post-exposure prophylaxis of COVID-19 in certain
individuals. As part of the agreement, Lilly will supply 614,000
doses of bamlanivimab with etesevimab no later than
January 31, 2022 for a total of $1.29
billion. A minimum of 400,000 doses will be supplied no
later than December 31, 2021.
The estimated impact of the new purchase to the 2021 guidance
provided in Lilly's earnings release dated October 26, 2021 is $840
million of additional revenue and approximately 25
cents of additional earnings per share. The expected impact in
2022 will be reflected in the company's financial guidance to be
provided in December 2021.
For more information about the use of bamlanivimab with
etesevimab to treat COVID-19, click here or contact Lilly's 24-hour
support line at 1-855-LillyC19 (1-855-545-5921). For media
resources, including product images and fact sheets, please
click here.
This purchase has been supported in whole or in part with
federal funds from the Department of Health and Human Services;
Office of the Assistant Secretary for Preparedness and Response;
Biomedical Advanced Research and Development Authority (BARDA),
under Contract No. W911QY21D0012.
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 or post-exposure prophylaxis 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
TREATMENT
Bamlanivimab and etesevimab
together are authorized for the treatment of mild to moderate
coronavirus disease 2019 (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 progression to severe COVID-19, including
hospitalization or death.
Limitations of Authorized Use:
Treatment
Combined Frequency of Variants Resistant to
Bamlanivimab and Etesevimab
- Bamlanivimab and etesevimab are not authorized for use in
states, territories, and U.S. jurisdictions in which the combined
frequency of variants resistant to bamlanivimab and etesevimab
exceeds 5%.i
-
- A list of states, territories, and U.S. jurisdictions in which
bamlanivimab and etesevimab are and are not currently authorized is
available on the following FDA website.
Use in Patients Who Are Hospitalized or Who Require Oxygen
Due to COVID-19
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 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.
POST-EXPOSURE PROPHYLAXIS
Bamlanivimab and etesevimab
administered together are authorized in adults and pediatric
individuals (12 years of age or older weighing at least 40 kg) for
post-exposure prophylaxis of COVID-19 in individuals who are at
high risk for progression to severe COVID-19, including
hospitalization or death, and are:
- not fully vaccinatedii or who are
not expected to mount an adequate immune response to complete
SARS-CoV-2 vaccination (for example, individuals with
immunocompromising conditions including those taking
immunosuppressive medicationsiii) AND
-
- have been exposed to an individual infected with SARS-CoV-2
consistent with close contact criteria per Centers for Disease
Control and Prevention (CDC)iv OR
- who are at high risk of exposure to an individual infected with
SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other
individuals in the same institutional setting (for example, nursing
homes, prisons).
Limitations of Authorized Use: Post-Exposure
Prophylaxis
- Bamlanivimab and etesevimab are not authorized for use in
states, territories, and U.S. jurisdictions in which the combined
frequency of variants resistant to bamlanivimab and etesevimab
exceeds 5%.i
-
- A list of states, territories, and U.S. jurisdictions in which
bamlanivimab and etesevimab are and are not currently authorized is
available on the following FDA website.
- Post-exposure prophylaxis with bamlanivimab and etesevimab is
not a substitute for vaccination against COVID-19.
- Bamlanivimab and etesevimab together are not authorized for
pre-exposure prophylaxis for prevention of COVID-19.
Important Safety Information
There are limited
clinical data available for bamlanivimab and etesevimab. Serious
and unexpected adverse events may occur that have not been
previously reported with the use of bamlanivimab and etesevimab
together.
Warnings
Hypersensitivity Including Anaphylaxis
and Infusion-Related Reactions
Serious hypersensitivity
reactions, including anaphylaxis, have been observed with
administration of bamlanivimab and etesevimab. If signs and
symptoms of a clinically significant hypersensitivity reaction or
anaphylaxis occur, immediately discontinue administration and
initiate appropriate medications and/or supportive therapy.
Infusion-related reactions, occurring during the infusion and up
to 24 hours after infusion, 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, vasovagal reactions (e.g. presyncope, syncope), dizziness,
and diaphoresis.
Consider slowing or stopping the infusion and administer
appropriate medications and/or supportive care if an
infusion-related reaction occurs.
Hypersensitivity reactions occurring more than 24 hours after
the infusion have also been reported with the use of bamlanivimab
and etesevimab under Emergency Use Authorization.
Clinical Worsening After Receiving Bamlanivimab and
Etesevimab Administration
Clinical worsening of COVID-19
after administration of bamlanivimab and etesevimab together 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 and
etesevimab 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 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 Reactions
Adverse reactions observed in
those who have received bamlanivimab and etesevimab are anaphylaxis
(n=1, 0.07%) and infusion-related reactions (n=16, 1.1%). The
most common treatment-emergent adverse events included nausea,
dizziness, and pruritus. No treatment-emergent events
occurred in more than 1% of participants and rates were comparable
to placebo.
Use in Specific
Populations
Pregnancy
There are
insufficient data to evaluate a drug-associated risk of major birth
defects, miscarriage, or adverse maternal or fetal outcomes.
Bamlanivimab and etesevimab 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.
BM ET HCP EUA ISI 27AUG2021
About bamlanivimab and etesevimab
Bamlanivimab is a
recombinant, neutralizing human IgG1 monoclonal antibody (mAb)
directed against the spike protein of SARS-CoV-2. It was designed
to block viral attachment and entry into human cells, thus
neutralizing the virus. 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.
Bamlanivimab was identified from a blood sample taken from one of
the first U.S. patients who recovered from
COVID-19.
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.
Results from a Phase 2/3 study in people recently diagnosed with
COVID-19 in the ambulatory setting (BLAZE-1, NCT04427501) were
published in the New England Journal of
Medicine. Results from a Phase 3 study of
bamlanivimab in residents and staff at long-term care facilities
(BLAZE-2, NCT04497987) were published in the Journal of
American Medical Association (JAMA). A Phase 2 study
assessing the efficacy and safety of bamlanivimab alone, and
bamlanivimab with other neutralizing antibodies versus placebo for
the treatment of symptomatic low-risk COVID-19 in the outpatient
setting (BLAZE-4. NCT04634409) has completed enrollment.
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 therapies 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) and etesevimab (LY-CoV016)
together as a potential therapy for patients with COVID-19, the
supply, distribution and contracts with governments relating to
these therapies, and Lilly's development plans, 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 and
etesevimab together will prove to be a safe and effective treatment
or successful preventative therapy for COVID-19, that 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 and etesevimab 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.
i FDA will make this determination considering
current variant frequency data (available
at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-proportions.html),
trends in variant frequency over time, the precision of the
estimates and information regarding emerging variants of concern.
FDA will update the list of states, territories, and US
jurisdictions in which bamlanivimab and etesevimab are and are not
currently authorized as new data and information becomes available.
Healthcare providers should refer to the FDA website regularly for
updates. Healthcare providers should refer to the FDA website
regularly for updates.
ii Individuals are considered to be fully
vaccinated 2 weeks after their second vaccine dose in a 2-dose
series (such as the Pfizer or Moderna vaccines), or 2 weeks after a
single-dose vaccine (such as Johnson & Johnson's Janssen
vaccine). See this website for more
details: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully
vaccinated.html#vaccinated.
iii See this website for more
details: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
iv Close contact with an infected individual is
defined as: being within 6 feet for a total of 15 minutes or more,
providing care at home to someone who is sick, having direct
physical contact with the person (hugging or kissing, for example),
sharing eating or drinking utensils, or being exposed to
respiratory droplets from an infected person (sneezing or coughing,
for example). See this website for additional
details: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html.
Refer to:
Allison Howell;
howell_allison@lilly.com; 317-655-1106 (Media)
Kevin Hern; hern_kevin_r@lilly.com;
317-277-1838 (Investors)
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