Lilly's bamlanivimab and etesevimab together reduced hospitalizations and death in Phase 3 trial for early COVID-19

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Figure 1: Time to COVID-19 related hospitalization
"These positive results reinforce our previous findings and support the authorized dose of bamlanivimab 700 mg with etesevimab 1400 mg.?These compelling data ? in addition to the recent EUA from FDA, the CHMP decision from EMA and the recommendation for the therapy in the?National Institutes of Health's?COVID-19 Treatment Guidelines ? give healthcare providers additional information regarding the use of bamlanivimab and etesevimab together as a potentially life-saving treatment to help those most at risk for severe complications of COVID-19," said?Daniel Skovronsky, M.D., Ph.D.,?Lilly's chief scientific officer and president of?Lilly Research Laboratories.?"The consistent results observed in multiple cohorts of this trial over several months, even as new strains of COVID-19 have emerged, indicate bamlanivimab with etesevimab maintains its effects against a range of variants, particularly those circulating in the?U.S."
Lilly?continues to engage with global regulators to make bamlanivimab alone and bamlanivimab and etesevimab together available around the world. Bamlanivimab alone and bamlanivimab with etesevimab together are authorized under special/emergency pathways, in the context of the pandemic, in the?U.S.?and the?European Union. In addition, bamlanivimab alone is authorized for emergency use in?Canada,?Panama,?Kuwait, the?UAE,?Israel,?Rwanda,?Morocco?and?numerous other countries. Through?Lilly's work with the?Bill & Melinda Gates Foundation,?Lilly?is providing doses of bamlanivimab free of charge in?Rwanda?and?Morocco.
For more information about the use of bamlanivimab alone or 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?lillyantibody.com?to learn more, including how to find a potential treatment location.
For media resources, including product images and fact sheets, please click?here.
Important Information about bamlanivimab alone and bamlanivimab and etesevimab together
Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together or bamlanivimab alone are?safe and effective for the treatment of COVID-19.
Bamlanivimab and etesevimab together and bamlanivimab alone 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 bamlanivimab alone 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. Please see the?FDA Letter of Authorization,?Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers?(English) (Spanish) for bamlanivimab alone.
Authorized Use and Important Safety Information
Bamlanivimab and etesevimab together and bamlanivimab alone 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 and bamlanivimab alone 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. Benefit of treatment with bamlanivimab alone has not been observed 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.
- 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.
Refer to: | Molly McCully;?mccully_molly@lilly.com; 317-478-5423 (Media) |
Dani Barnhizer;?dbarnhizer@lilly.com; 317-607-6119 (Media) | |
Kevin Hern;?hern_kevin_r@lilly.com; 317-277-1838 (Investors) |