This week marks an important milestone in our fight against the COVID-19 pandemic, as the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Eli Lilly and Company’s investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg.
Bamlanivimab is now authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA is based on data from BLAZE-1, a randomized, double-blind, placebo-controlled Phase 2 study in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting. For more on results from the Phase 2 study, read the full press release here.
The authorized dosage for bamlanivimab is a single intravenous (IV) infusion of 700 mg administered as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset. The U.S. government has purchased 300,000 doses and has committed that Americans will have no out-of-pocket costs for the medicine, although healthcare facilities may charge a fee for the product's administration.
As the number of COVID-19 cases rise and we continue to navigate this unprecedented time together, Lilly is committed to ensuring our healthcare providers and patients have the answers they need. Several resources are already available to help you understand more about the FDA’s Emergency Use Authorization for bamlanivimab:
- For more information about the EUA and bamlanivimab, visit bamlanivimab.com. Here you will also find the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers.
- For the most up-to-date information regarding access, health care providers should contact their state health department directly. A list can be found here.
- Please direct all questions to our dedicated Lilly COVID-19 Hotline at 1-855-545-5921. While we know you may work with a Lilly Sales Professional in your office, this hotline will be the fastest way to provide information regarding Lilly’s COVID-19 Antibody Program.
The emergency use authorization marks an important breakthrough in our fight against the COVID-19 pandemic. This would not have been possible without the collaboration of key partners and organizations within our government and across the healthcare industry. We are grateful to those partners – and to you, our healthcare providers – as together we work to attack this virus.
Thank you for the work you continue to do on the front lines every day, and please know that we remain committed to supporting you and your patients, always.
Authorized Use and Important Safety Information
Bamlanivimab is authorized for use for treatment of mild to moderate COVID-19 in adults and pediatric patients with positive results of direct SARS-CoV-2 viral testing who are 12 years of age and older weighing at least 40 kg, and who are at high risk for progressing to severe COVID-19 and/or hospitalization.
- Bamlanivimab has not been approved, but has been authorized for emergency use by FDA.
- Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the 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.
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 in hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.
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 with COVID-19 requiring high flow oxygen or mechanical ventilation. See Limitations of Authorized Use.
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
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.
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.
Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bamlanivimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and Fact Sheet for Patients, Parents and Caregivers.