INDIANAPOLIS,?Dec. 18, 2020?/PRNewswire/ --?Eli Lilly and Company (NYSE:?LLY) today announced plans to begin a new pragmatic study of bamlanivimab (LY-CoV555) in high-risk patients with COVID-19, in collaboration with major local institutions in the state of?New Mexico. Conducting the study in?New Mexico?will allow for the collection of data on the effectiveness and safety of bamlanivimab in a real-world setting that includes a diverse population and spans both rural and urban environments.

Bamlanivimab recently received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization.

"It is important to continue building on the evidence base for bamlanivimab through ongoing studies, including those in a real-world setting," said?Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "In addition to gathering treatment and safety data, Lilly will use this study to explore the delivery of bamlanivimab in a variety of innovative infusion settings, which could help inform best practices and ultimately replication by institutions around the country."

The study will begin in the coming weeks and will evaluate the effectiveness of bamlanivimab in reducing COVID-19 hospitalizations in a high-risk population. Under the study design, a variety of infusion settings will be utilized across the state, allowing access to multiple diverse communities ? including Native American communities.?As part of this study, Lilly will employ its unique mobile research units used successfully in other studies. These units include a custom retrofitted recreational vehicle (RV) solution to support mobile labs and clinical trial material preparation, along with a support vehicle to deliver all clinical trial supplies needed to create an on-site infusion clinic for patients who may otherwise not be able to participate in a clinical study due to lack of access.

Important Information about bamlanivimab??
Bamlanivimab has not been approved by the FDA for any use.? It is not known if bamlanivimab is safe and effective for the treatment of COVID-19.

Bamlanivimab is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bamlanivimab 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 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).

Authorized Use and Important Safety Information
Bamlanivimab 700 mg injection is authorized for use under an 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 is 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.
• Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19.

Important Safety Information
There are limited clinical data available for bamlanivimab. Serious and unexpected adverse events may occur that have not been previously reported with bamlanivimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
There is a potential for serious hypersensitivity reaction, including anaphylaxis, with administration of bamlanivimab. 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. Signs and symptoms of infusion-related reactions may include:

• fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness.

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19
Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19.? Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes when administered to hospitalized patients requiring high flow oxygen or mechanical ventilation with COVID-19. See Limitations of Authorized Use.

Adverse Events
Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg and 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 during pregnancy. Bamlanivimab 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 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 study in people recently diagnosed with COVID-19 in the ambulatory setting (BLAZE-1,?NCT04427501) is ongoing, testing bamlanivimab alone and in combination with a second antibody. Data from the monotherapy arms of BLAZE-1 were published in the?New England Journal of Medicine. A Phase 3 study of bamlanivimab for the prevention of COVID-19 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 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 novel antibody treatments for COVID-19. Lilly is testing both single antibody therapy as well as combinations of antibodies as potential therapeutics for COVID-19. Click?here?for resources related to Lilly's COVID-19 efforts.

About Eli Lilly and Company??
Lilly is a global healthcare 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) as a potential treatment for patients with or at risk of infection from COVID-19, as well as collection of data regarding its effectiveness, its supply and delivery, 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 will prove to be a safe and effective treatment or preventative for COVID-19,?that patients will volunteer to participate in the study or achieve positive outcomes,?that bamlanivimab will receive regulatory approvals or additional authorizations, or that we can provide an adequate supply of bamlanivimab 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.?

SOURCE Eli Lilly and Company

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