Lilly and UnitedHealth Group partner on pragmatic study of neutralizing antibody bamlanivimab (LY-CoV555) for COVID-19
INDIANAPOLIS and MINNETONKA, Minn., Dec. 4, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and UnitedHealth Group (NYSE: UNH) today announced a partnership to conduct a pragmatic study of bamlanivimab (LY-CoV555) in high-risk, COVID-19 infected individuals.
Bamlanivimab recently received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration for the treatment of mild to moderate COVID-19 patients who are at high risk for progressing to severe COVID-19 and/or hospitalization. The trial will evaluate the efficacy and safety of bamlanivimab versus a propensity-matched control in individuals that meet the EUA criteria.
The study will identify and treat a large, diverse population of high-risk individuals for COVID-19 with bamlanivimab under real-world conditions with a goal of reducing the severity of illness and hospitalizations. It will draw upon both UnitedHealth Group's UnitedHealthcare health benefits business as well as its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing and in-home infusion services.
Delivering bamlanivimab to patients through home infusions allows them to stay quarantined and at home, minimizing the potential spread of COVID-19.
"While bamlanivimab is authorized for emergency use based on the efficacy and safety data accumulated to date, larger pragmatic studies in diverse populations can help us further understand the efficacy and safety of SARS-CoV-2 neutralizing antibodies in real world settings," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "Lilly is excited to partner with UnitedHealth Group to study our antibody therapy using a care delivery model that will allow rapid diagnosis and in-home treatment of patients at a high risk of complications."
Under the study design, UnitedHealthcare Medicare Advantage members who meet the FDA-authorized criteria for treatment will be invited to volunteer for the study through United in Research, a UnitedHealth Group virtual community and technology platform for citizen scientists.
Those who volunteer and are in an area where they can receive treatment will be directed to download Optum's symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab. The study will enroll up to 500,000 people, with at least 5,000 people expected to receive bamlanivimab therapy.
"Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available," said Ken Ehlert, chief scientific officer, UnitedHealth Group and chief executive officer, OptumLabs. "Intercepting the disease before it escalates may help to keep people out of the hospital and reduce the overwhelming burden on the healthcare system. By bringing together UnitedHealth Group's expertise in science, clinical research, and technology, with Lilly's expertise in pharmaceutical development, we can responsibly and safely accelerate research on this new potential COVID-19 treatment."
This study is part of a collaborative partnership between OptumLabs, the scientific research arm of UnitedHealth Group, and Lilly to advance cutting-edge science, research, and solutions that will accelerate the progression of validated therapies into real world applications.
Important Information about bamlanivimab
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
Limitations of Authorized Use
Important Safety Information
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions
Infusion-related reactions have been observed with administration of bamlanivimab. Signs and symptoms of infusion-related reactions may include:
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
Use in Specific Populations
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 the UNITED Trial
About Lilly's COVID-19 Efforts
About Eli Lilly and Company
About UnitedHealth Group
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 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.
UnitedHealth Group Forward-Looking Statements
This press release contains statements, estimates, projections, guidance or outlook that constitute "forward-looking" statements as defined under U.S. federal securities laws. We caution that actual results could differ materially from those that management expects, depending on the outcome of certain factors. A list and description of some of these risks and uncertainties can be found in our reports filed with the Securities and Exchange Commission from time to time, including the cautionary statements in our annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Any or all forward-looking statements we make may turn out to be wrong. 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 bamlanivimab will receive regulatory approvals or additional authorizations, or that an adequate supply of bamlanivimab can be provided to patients in all circumstances. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We do not undertake to update or revise any forward-looking statements, except as required by applicable securities laws.
View original content to download multimedia:http://www.prnewswire.com/news-releases/lilly-and-unitedhealth-group-partner-on-pragmatic-study-of-neutralizing-antibody-bamlanivimab-ly-cov555-for-covid-19-301186265.html
SOURCE Eli Lilly and Company
Company Codes: NYSE:LLY, NYSE:UNH