INDIANAPOLIS, April 16, 2021 /PRNewswire/ -- Eli Lilly and
Company (NYSE: LLY) has requested the U.S. Food and Drug
Administration (FDA) revoke the Emergency Use Authorization (EUA)
for bamlanivimab (LY-CoV555) 700 mg alone. Lilly made this request
due to the evolving variant landscape in the U.S. and the full
availability of bamlanivimab and etesevimab together. This request
is not due to any new safety concern.
This final step in Lilly's transition to only supply
bamlanivimab and etesevimab for administration together in the U.S.
for the treatment of COVID-19 – as planned with the FDA – follows
the modification of contracts with the U.S. government to ensure
adequate supply of etesevimab to be used together with
bamlanivimab.
All sites in the U.S. now have access to obtain doses of
etesevimab for administration with bamlanivimab—which together
neutralize more of the emerging COVID-19 variants in the U.S. than
bamlanivimab alone, including the rapidly growing B.1.427/B.1.429
California strain that currently
accounts for 50 percent of the virus in California and over 10 percent across a number
of additional states. In the U.S., bamlanivimab alone should no
longer be administered. However, sites of care should not dispose
of bamlanivimab supply; instead, they should order etesevimab to
pair with it.
"Lilly moved quickly to make bamlanivimab alone available as a
potentially lifesaving medicine at a time when Americans were
hardest hit by COVID-19," said Daniel Skovronsky, M.D.,
Ph.D., Lilly's chief scientific officer and president
of Lilly Research Laboratories. "With the growing
prevalence of variants in the U.S.
that bamlanivimab alone may not fully neutralize,
and with sufficient supply
of etesevimab, we believe now is the
right time to complete our planned transition and focus on the
administration of these two neutralizing antibodies
together."
Lilly's bamlanivimab was the first neutralizing monoclonal
antibody to receive emergency use authorization from the
FDA as a treatment for mild to moderate COVID-19 — providing a
valuable treatment at a time when cases were at their highest in
the U.S. More than 400,000 patients have been treated with
bamlanivimab – more than any other neutralizing antibody –
potentially preventing more than 20,000 hospitalizations and at
least 10,000 deaths during the worst of the pandemic in the
U.S.
Lilly developed bamlanivimab and etesevimab for administration
together to meet the potential challenge of treatment-resistant
variants likely to resist treatment with either monoclonal
antibody used alone. Due to the rapidly evolving and geographically
diverse nature of the SARS-CoV-2 virus, continued scientific
innovation remains critical to develop additional treatments. Lilly
remains committed to developing complementary neutralizing
antibodies to address potential SARS-CoV-2 variants that may arise
in the future.
Bamlanivimab and/or bamlanivimab administered with etesevimab
are authorized under special pathways in 20 countries outside the
U.S. spanning four continents. Both bamlanivimab alone and
bamlanivimab and etesevimab together retain the neutralization
effects against the vast majority of variants, including the UK
(B.1.1.7.) variant, present in these other countries and remain an
important treatment option. The degree of neutralization of the
virus does not necessarily equate to improved clinical
outcomes.
Lilly is not requesting the withdrawal of emergency
authorization for bamlanivimab alone in any other jurisdiction at
this time. However, its use together with etesevimab, where
authorized and available, is preferred over bamlanivimab alone.
Lilly, in collaboration with Amgen, expects to manufacture
sufficient supply of bamlanivimab and etesevimab together to meet
global supply needs. Going forward, Lilly will submit only
bamlanivimab administered with etesevimab together for
authorization globally with a full transition expected by
June 2021.
For more information about the use of bamlanivimab and
etesevimab together for the treatment of mild to moderate COVID-19
in high-risk patients under the FDA's emergency use authorization,
contact Lilly's 24-hour support line at 1-855-LillyC19
(1-855-545-5921). Patients and physicians can visit
covid.infusioncenter.org or the HHS Therapeutics Distribution
locator to find a potential treatment 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 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
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 treatment for patients with COVID-19, as
well as bamlanivimab (LY-CoV555) alone and etesevimab (LY-CoV016)
alone, the supply, distribution and contracts with the U.S.
government 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.
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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