INDIANAPOLIS, Dec. 3, 2021 /PRNewswire/ -- The U.S. Food
and Drug Administration (FDA) has expanded the Emergency Use
Authorization (EUA) for bamlanivimab and etesevimab administered
together to include certain high-risk pediatric patients from birth
to <12 years old, Eli Lilly and Company (NYSE: LLY) announced
today. This expansion allows for bamlanivimab and etesevimab to be
administered together in high-risk pediatric patients for the
treatment of mild to moderate COVID-19 as well as post-exposure
prophylaxis.
"Our mission since the start of the pandemic has been to offer
crucial support by developing therapeutic options that could
prevent hospitalization and death for as many people as possible,"
said Daniel Skovronsky, M.D., Ph.D.,
Lilly's chief scientific and medical officer, and president of
Lilly Research Laboratories. "With the FDA's decision to allow use
of bamlanivimab with etesevimab in children and infants, Lilly can
now offer treatment and prevention options to high-risk individuals
of any age."
The expanded authorization is based on safety and efficacy data
of pediatric and infant patients in BLAZE-1, a phase 2/3 clinical
trial studying bamlanivimab and etesevimab administered together
for the treatment of mild to moderate COVID-19 and who are at high
risk for severe disease progression. The median time to complete
symptom resolution as recorded in a trial specific daily symptom
diary was 7 days for subjects treated with bamlanivimab 700 mg and
etesevimab 1,400 mg and 5 days for subjects treated with
weight-based dosing of bamlanivimab and etesevimab. No pediatric
subject died or required hospitalization due to COVID-19.
Bamlanivimab and etesevimab, when administered together, retain
neutralization activity against the Delta variant, which is the
predominant variant of concern within the U.S. Lilly has performed
pseudovirus and authentic virus studies to confirm that
bamlanivimab with etesevimab retain neutralization activity against
the Delta variant of concern. Lilly is working quickly to
understand neutralization activity of our therapies on the Omicron
variant of concern.
To date, over 700,000 patients have been treated
with bamlanivimab or bamlanivimab and
etesevimab, potentially preventing more than 35,000
hospitalizations and at least 14,000 deaths during the worst of the
pandemic.
For more information about the use of bamlanivimab and
etesevimab together for the treatment of mild to moderate COVID-19
and prevention of COVID-19 in high risk pediatric and infant
patients under the FDA's emergency use authorization,
please see the Fact Sheet for Healthcare Providers, and Fact Sheet
for Patients, Parents and Caregivers (English) (Spanish),
click here or contact Lilly's 24-hour support line
at 1-855-LillyC19 (1-855-545-5921). Patients and physicians can
visit the NICA Infusion Center Locator or the HHS
Therapeutics Distribution locator to find a potential therapy
location.
For media resources, including product images and fact sheets,
please click here.
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
The U.S. Food and Drug Administration (FDA) has issued an
Emergency Use Authorization (EUA) to permit the emergency use of
the unapproved products bamlanivimab and etesevimab administered
together for the treatment of mild to moderate coronavirus disease
2019 (COVID-19) in adults and pediatric patients, including
neonates, 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 US jurisdictions in which the combined
frequency of variants resistant to bamlanivimab and etesevimab
exceeds 5%.1
-
- A list of states, territories, and US 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 2 years and older who are hospitalized due to
COVID-192,
- Bamlanivimab and etesevimab are not authorized for use in
patients, regardless of age, who:
-
- require oxygen therapy and/or respiratory support due to
COVID-19, OR
- require an increase in baseline oxygen flow rate and/or
respiratory support due to COVID-19 and are on chronic oxygen
therapy and/or respiratory support 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.
POST-EXPOSURE PROPHYLAXIS
Bamlanivimab and etesevimab administered together are authorized
for post-exposure prophylaxis of COVID-19 in adults and pediatric
individuals, including neonates, who are at high risk for
progression to severe COVID-19, including hospitalization or death,
and are:
- not fully vaccinated3 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 medication4) 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)5 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 US jurisdictions in which the combined
frequency of variants resistant to bamlanivimab and etesevimab
exceeds 5%.1
-
- A list of states, territories, and US 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 together. Serious and unexpected adverse events may
occur that have not been previously reported with bamlanivimab and
etesevimab together.
Warnings and Precautions
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 care.
Infusion-related reactions, occurring during or 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 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: Treatment for more.
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 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.
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 has utilized the full force of its expertise to develop
the first monoclonal antibody authorized for Emergency Use (EUA) by
the U.S. Food and Drug Administration (FDA) – bamlanivimab,
followed by the authorization of bamlanivimab with etesevimab and
exploring other novel antibodies for potential treatment.
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, as well as bamlanivimab (LY-CoV555) alone, the supply,
distribution and contracts with the 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 or
any other therapy will prove to be safe and effective treatments or
successful preventative therapies for COVID-19, that bamlanivimab
and etesevimab together or any other therapy 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
or any other therapy 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.
PP-BE-US-0115 12/2021 ©Lilly USA, LLC 2021. All rights reserved.
1FDA 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.
2The reasons for hospital admission may be different
and the threshold for hospital admission may be lower for neonates,
young infants and toddlers with COVID-19 compared to older children
and adults. The authorization allows for young children (i.e.,
birth to 2 years of age) who are hospitalized with mild to moderate
COVID-19 at the time of treatment to receive bamlanivimab and
etesevimab.
3Individuals 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).
4See this website for more details:
https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.
5Close 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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